Responsibilities:

• Collaborating with Process Engineer & Engineering team to establish QC standards.
• Creating documentation for inspection criteria and quality plans.
• Collaborating with QA, Process, and Product teams to address quality issues through corrective action.
• Conducting in-process audits and final quality control audits with the Process team.

Requirements:

• Diploma in Manufacturing/Quality Engineering or equivalents.
• Minimum 1 year of working experience in Electronics Manufacturing Industry.
• Responsible for controlling Supplier Quality Assurance (SQA).
• Oversight of quality control for incoming, in-process, and outgoing products.
• Knowledgeable in ISO 9001, 14001, 13485, and 45001, and FDA requirements.
• Understanding IPC requirements in PCB assembly and quality standards for various manufacturing processes such as plastic molding, die casting, extrusion, metal stamping, and machining parts.

_______________________________________________________

HOW TO APPLY :

Interested candidates, please submit your resume by clicking on “Quick Apply” or contact win@hkmsvs.com for more details.

Please provide following information in the resume for immediate processing

1) Reasons for leaving current and/or last employment

2) Last drawn and/or current salary

3) Expected salary

4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

Wee Wai Dan

EA License No : 03C5391

EA Reg No : R22109628

Responsibilities:

• Collaborating with Process Engineer & Engineering team to establish QC standards.
• Creating documentation for inspection criteria and quality plans.
• Collaborating with QA, Process, and Product teams to address quality issues through corrective action.
• Conducting in-process audits and final quality control audits with the Process team.

Requirements:

• Diploma in Manufacturing/Quality Engineering or equivalents.
• Minimum 1 year of working experience in Electronics Manufacturing Industry.
• Responsible for controlling Supplier Quality Assurance (SQA).
• Oversight of quality control for incoming, in-process, and outgoing products.
• Knowledgeable in ISO 9001, 14001, 13485, and 45001, and FDA requirements.
• Understanding IPC requirements in PCB assembly and quality standards for various manufacturing processes such as plastic molding, die casting, extrusion, metal stamping, and machining parts.

_______________________________________________________

HOW TO APPLY :

Interested candidates, please submit your resume by clicking on “Quick Apply” or contact win@hkmsvs.com for more details.

Please provide following information in the resume for immediate processing

1) Reasons for leaving current and/or last employment

2) Last drawn and/or current salary

3) Expected salary

4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

Wee Wai Dan

EA License No : 03C5391

EA Reg No : R22109628

Responsibilities:

• Collaborating with Process Engineer & Engineering team to establish QC standards.
• Creating documentation for inspection criteria and quality plans.
• Collaborating with QA, Process, and Product teams to address quality issues through corrective action.
• Conducting in-process audits and final quality control audits with the Process team.

Requirements:

• Diploma in Manufacturing/Quality Engineering or equivalents.
• Minimum 1 year of working experience in Electronics Manufacturing Industry.
• Responsible for controlling Supplier Quality Assurance (SQA).
• Oversight of quality control for incoming, in-process, and outgoing products.
• Knowledgeable in ISO 9001, 14001, 13485, and 45001, and FDA requirements.
• Understanding IPC requirements in PCB assembly and quality standards for various manufacturing processes such as plastic molding, die casting, extrusion, metal stamping, and machining parts.

_______________________________________________________

HOW TO APPLY :

Interested candidates, please submit your resume by clicking on “Quick Apply” or contact win@hkmsvs.com for more details.

Please provide following information in the resume for immediate processing

1) Reasons for leaving current and/or last employment

2) Last drawn and/or current salary

3) Expected salary

4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

Wee Wai Dan

EA License No : 03C5391

EA Reg No : R22109628

Quality Lead/ Supervisor (QAQC)

Location: Penjuru Place (shuttle bus provided)

Monday - Friday 8am - 5.30pm

The Quality Lead/ Supervisor is responsible for ensuring timely and effective implementation of the company's policies, procedures, and standards involved in assuring the quality of manufactured products and customer satisfaction, as well as for conducting quality control activities. The Quality Supervisor strives to ensure the facility adheres to quality licenses, standards and certifications.

A successful candidate will collaborate closely with functional areas such as Manufacturing, Procurement, Mfg. Engineering, Sustaining Engineering, Product Lines, R&M and Geozones regularly as well as presenting to internal teams plans and updates.

Job Responsibilities:

• Supervise and lead 4 Quality Control Inspectors and liaise with internal & external stakeholders.
• Maintain site Quality Management System.
• Update QMS records and maintain all necessary documentation and certificates.
• Responsible for following management of change as processes and procedures are updated as per QMS requirements.
• Perform regular process audits in Manufacturing areas and functional areas, including technical work instructions, processes, procedures, and competence and ensure compliance.
• Generate CARs related to any deficiencies and track them to completion.
• Keep competency records up-to-date.
• Conduct training related to QMS, procedures, WIs, others.
• Actively participate in Contract Reviews.
• Develop customer QCP Plans. Ensure contractual requirements are built into Quality Control plans.
• Actively participate in Pre-Production meetings.
• Coordinate Client visits, and audits and constant communication to demonstrate our commitment and promote the Corporate Quality Management System.
• Drive action trackers to completion, related to customer audits, manufacturing reviews or qualification process.
• Coordinate TPIs per customer QCPs, and per production schedule. Ensure documentation meet requirements.
• Review/release WOs from a Quality point of view.
• CPARs/NCRs/COPQ; monitor performance/trends, data analysis, and evaluate the effectiveness of corrective actions to ensure that the required improvements are sustained. Actively participate in RCA. Monitor/track other Quality KPIs.
• Coordinate with product design engineers and manufacturing engineers the requirements in the quality plans and inspection and test plans to be aligned with their engineering design criteria, production schedules and customer requirements.
• Coordinate quality assurance plans for new PNs/product introductions.
• Review and approval purchased materials/products mill test certificates if it complies with the required company specifications and/or applicable industry standards prior to acceptance and use.
• Ensure quality control inspection and testing activities are performed in accordance with Global MFG QMS, customer QCPs/Inspection matrices, and/or local procedires and work instructions.
• Manage non-conformance process in accordance with Global MFG QMS.
• Identify a minimum of two continuous improvement projects per year to lead and complete with measurable improvement to the business in terms of margin, quality, etc
• Any other delegated responsibilities as instructed by his direct supervisor within the timeframe specified safely and efficiently to meet business requirements, provided the instruction is reasonable and you are capable and deemed competent to fulfil these.

Job Requirements:

• 5 to 8 years of experience with ISO-9001
• Minimum 5 years of experience in QA/QC role in the manufacturing environment
• Excellent written, reading, and oral communication in English
• Computer literate and familiar with Microsoft Office software at a minimum
• Fast learner, results-oriented and independent with strong interpersonal skills
• Possess strong customer service skills, i.e. listening, follow-through, and willingness to help
• Certified Auditor
• Ability to read engineering drawings
• Ability to interpret MTCs (Material Test Certificates) against the Company specifications
• Skilled at data mining (Excel Pivot Tables, other Excel tools)

Preferred

• Lean / Six Sigma experience
• Certified Lead Auditor
• Root Cause Analysis implementation experience
• Power BI dashboards.

SR Quality / Quality Lead/ Supervisor (QAQC)

Location: Penjuru Place (shuttle bus provided)

Monday - Friday 8am - 5.30pm

The Quality Lead/ Supervisor is responsible for ensuring timely and effective implementation of the company's policies, procedures, and standards involved in assuring the quality of manufactured products and customer satisfaction, as well as for conducting quality control activities. The Quality Supervisor strives to ensure the facility adheres to quality licenses, standards and certifications.

A successful candidate will collaborate closely with functional areas such as Manufacturing, Procurement, Mfg. Engineering, Sustaining Engineering, Product Lines, R&M and Geozones regularly as well as presenting to internal teams plans and updates.

Job Responsibilities:

• Supervise and lead 4 Quality Control Inspectors and liaise with internal & external stakeholders.
• Maintain site Quality Management System.
• Update QMS records and maintain all necessary documentation and certificates.
• Responsible for following management of change as processes and procedures are updated as per QMS requirements.
• Perform regular process audits in Manufacturing areas and functional areas, including technical work instructions, processes, procedures, and competence and ensure compliance.
• Generate CARs related to any deficiencies and track them to completion.
• Keep competency records up-to-date.
• Conduct training related to QMS, procedures, WIs, others.
• Actively participate in Contract Reviews.
• Develop customer QCP Plans. Ensure contractual requirements are built into Quality Control plans.
• Actively participate in Pre-Production meetings.
• Coordinate Client visits, and audits and constant communication to demonstrate our commitment and promote the Corporate Quality Management System.
• Drive action trackers to completion, related to customer audits, manufacturing reviews or qualification process.
• Coordinate TPIs per customer QCPs, and per production schedule. Ensure documentation meet requirements.
• Review/release WOs from a Quality point of view.
• CPARs/NCRs/COPQ; monitor performance/trends, data analysis, and evaluate the effectiveness of corrective actions to ensure that the required improvements are sustained. Actively participate in RCA. Monitor/track other Quality KPIs.
• Coordinate with product design engineers and manufacturing engineers the requirements in the quality plans and inspection and test plans to be aligned with their engineering design criteria, production schedules and customer requirements.
• Coordinate quality assurance plans for new PNs/product introductions.
• Review and approval purchased materials/products mill test certificates if it complies with the required company specifications and/or applicable industry standards prior to acceptance and use.
• Ensure quality control inspection and testing activities are performed in accordance with Global MFG QMS, customer QCPs/Inspection matrices, and/or local procedires and work instructions.
• Manage non-conformance process in accordance with Global MFG QMS.
• Identify a minimum of two continuous improvement projects per year to lead and complete with measurable improvement to the business in terms of margin, quality, etc
• Any other delegated responsibilities as instructed by his direct supervisor within the timeframe specified safely and efficiently to meet business requirements, provided the instruction is reasonable and you are capable and deemed competent to fulfil these.

Job Requirements:

• 5 to 8 years of experience with ISO-9001
• Minimum 5 years of experience in QA/QC role in the manufacturing environment
• Excellent written, reading, and oral communication in English
• Computer literate and familiar with Microsoft Office software at a minimum
• Fast learner, results-oriented and independent with strong interpersonal skills
• Possess strong customer service skills, i.e. listening, follow-through, and willingness to help
• Certified Auditor
• Ability to read engineering drawings
• Ability to interpret MTCs (Material Test Certificates) against the Company specifications
• Skilled at data mining (Excel Pivot Tables, other Excel tools)

Preferred

• Lean / Six Sigma experience
• Certified Lead Auditor
• Root Cause Analysis implementation experience
• Power BI dashboards.

The QC Supervisor role manages Analytical & Packaging labs in Concentrate operations. The primary purposes of the role are to ensure Quality Control processes and policies are established in all labs as per PGCS requirements, responsible for day-to-day quality management, issues resolution and continual improvements through collaboration with Supply Chain and Manufacturing.

Responsibilities:

• Lead & manage Analytical (Raw material, Finished good), Sensory, Micro and Packaging lab operations.
• Ensure Laboratory operations in compliance with PepsiCo/PGCS Lab programs.
• Drive Partnership with Operations and Supply Chain functions on daily Lab mgmt. test TAT, batching resolution, Hold/release, Vendor NCR mgmt. New product validation process etc.
• Responsible for Key KPI’s – Laboratory program compliance, Testing TAT, Lab capacity demand, Quality reserves, and Cost mgmt.
• Drive continual improvement in Key Quality metrics through simplification, Kaizen projects with support from site leadership team and support centre.
• Manage Lab analysts people process as per PepsiCo policy.
• Execute Corporate Quality procedures compliance relevant to this job profile.
• Drive best practise – sharing, standardization, and harmonization of programs and practises implemented in other PGCS plants.
• Lead the implementation of Laboratory productivity initiatives to drive efficiency.
• Liaise with R&D/Support centre as required.
• Adhere to all PepsiCo Health & Safety requirements
• Process owner for:

1. Lab operations and planning
2. Issue resolution relate with RMPM and BC
3. GCS control owner
4. Hold / Release and Quality reserves management
5. AOP planning and budget mgmt.

Qualifications

• Bachelor’s degree in science, Food Technology, Chemistry, or any other related discipline
• Minimum 7 years of relevant experience as a supervisor in operating Laboratory environment
• Experience in People Management and prior supervisory skill
• Possess knowledge of and experience in GLP, HPLC / GC operation, SAP QM module and LIMS management
• Strong leadership presence, ability to manage and co-ordinate with cross-functional teams on investigation analysis, troubleshooting and issues resolution
• Ability to lead change and drive behaviors.
• Ability to organize and manage multiple priorities in high-pressure work environment.
• Strong collaboration and influencing skills
• Excellent communication and interpersonal skills, both verbal and written with ability to clearly articulate ideas and proposals to all levels of the organization
• Positive and Can-do Attitude
• Willing to stretch and take additional responsibilities when needed
• Lead by example to others
• Other Ad hoc duties

We regret to inform you that only shortlisted candidates will be notified.

SR Quality / Quality Lead/ Supervisor (QAQC)

Location: Penjuru Place (shuttle bus provided)

Monday - Friday 8am - 5.30pm

The Quality Lead/ Supervisor is responsible for ensuring timely and effective implementation of the company's policies, procedures, and standards involved in assuring the quality of manufactured products and customer satisfaction, as well as for conducting quality control activities. The Quality Supervisor strives to ensure the facility adheres to quality licenses, standards and certifications.

A successful candidate will collaborate closely with functional areas such as Manufacturing, Procurement, Mfg. Engineering, Sustaining Engineering, Product Lines, R&M and Geozones regularly as well as presenting to internal teams plans and updates.

Job Responsibilities:

• Supervise and lead 4 Quality Control Inspectors and liaise with internal & external stakeholders.
• Maintain site Quality Management System.
• Update QMS records and maintain all necessary documentation and certificates.
• Responsible for following management of change as processes and procedures are updated as per QMS requirements.
• Perform regular process audits in Manufacturing areas and functional areas, including technical work instructions, processes, procedures, and competence and ensure compliance.
• Generate CARs related to any deficiencies and track them to completion.
• Keep competency records up-to-date.
• Conduct training related to QMS, procedures, WIs, others.
• Actively participate in Contract Reviews.
• Develop customer QCP Plans. Ensure contractual requirements are built into Quality Control plans.
• Actively participate in Pre-Production meetings.
• Coordinate Client visits, and audits and constant communication to demonstrate our commitment and promote the Corporate Quality Management System.
• Drive action trackers to completion, related to customer audits, manufacturing reviews or qualification process.
• Coordinate TPIs per customer QCPs, and per production schedule. Ensure documentation meet requirements.
• Review/release WOs from a Quality point of view.
• CPARs/NCRs/COPQ; monitor performance/trends, data analysis, and evaluate the effectiveness of corrective actions to ensure that the required improvements are sustained. Actively participate in RCA. Monitor/track other Quality KPIs.
• Coordinate with product design engineers and manufacturing engineers the requirements in the quality plans and inspection and test plans to be aligned with their engineering design criteria, production schedules and customer requirements.
• Coordinate quality assurance plans for new PNs/product introductions.
• Review and approval purchased materials/products mill test certificates if it complies with the required company specifications and/or applicable industry standards prior to acceptance and use.
• Ensure quality control inspection and testing activities are performed in accordance with Global MFG QMS, customer QCPs/Inspection matrices, and/or local procedires and work instructions.
• Manage non-conformance process in accordance with Global MFG QMS.
• Identify a minimum of two continuous improvement projects per year to lead and complete with measurable improvement to the business in terms of margin, quality, etc
• Any other delegated responsibilities as instructed by his direct supervisor within the timeframe specified safely and efficiently to meet business requirements, provided the instruction is reasonable and you are capable and deemed competent to fulfil these.

Job Requirements:

• 5 to 8 years of experience with ISO-9001
• Minimum 5 years of experience in QA/QC role in the manufacturing environment
• Excellent written, reading, and oral communication in English
• Computer literate and familiar with Microsoft Office software at a minimum
• Fast learner, results-oriented and independent with strong interpersonal skills
• Possess strong customer service skills, i.e. listening, follow-through, and willingness to help
• Certified Auditor
• Ability to read engineering drawings
• Ability to interpret MTCs (Material Test Certificates) against the Company specifications
• Skilled at data mining (Excel Pivot Tables, other Excel tools)

Preferred

• Lean / Six Sigma experience
• Certified Lead Auditor
• Root Cause Analysis implementation experience
• Power BI dashboards.

Job Description: Electronic Test Technician/AE

The job description:

Assist the engineer to set up test system and conduct system test of IOT eco-system. Occasionally may require to participates in NPI for new product launch. The person may interact with automated machine and occasionally make changes to simple C#/python programming. Work independently and traveling to manufacturing site may be require occasionally.

Responsibilities:

1. Assist engineer to setup test benches for IOT system testing.

2. Able to perform simple electrical and mechanical maintenance and trouble shooting.

3. Communicate or document failure observed in excel for communication with wider team members.

4. Maintain lab accessories and assist engineer to perform measurement/ testing.

5. Able to perform statistical analysis, but not mandatory.

Qualifications:

1. Diploma in electronic/electric engineering. Fresh graduation is encouraged to apply.

2. Eager to learn new skills and hand-on person.

3. Candidate with more years of experience will be consider more senior position.

4. Adequate knowledge of PLC system, Laser engraving and Camera vision inspection technology application

5. Knowledge of national electrical standard, Strong self-learning ability

6. Familiar with industry automation theory and electric power system

7. Electric automation design ability and experience of electric equipment installation is preferred.

8. Knowledge of maintenance system i.e. TPM etc. and electric safety

9. Experience in Project management is preferred.

10. Excellent verbal and written communication in English language.

11. Verbal and written communication in Chinese is a plus point

• To conduct internal and external audits and maintained the audits schedule.
• Responsible for Compliance activities in the plant.
• Responsible for managing the supplier quality program.
• Responsible for SAP & POMS changes and verification of recipes, inspection plan etc.
• To ensure all complaints are properly investigation per Abbott's requirements and responded to affiliates in a timely manner.
• Works with cross-functional teams to identify cause, track progress and drive resolution of quality issues.
• To ensure metrics for complaints are collated and trend.
• Responsible for the QA related activities for New product introduction.
• Knowledge of basic principles, methods, technologies and practices of a professional/ technical field.
• General knowledge of procedures and activities within own work area.
• Focused on learning the key aspects and duties of the job being performed.
• Applied research, information gathering and analytical skills.
• Handle detailed, structured problems.
• Works on assignments where judgements is required a majority of the time.
• Works under general direction, seeks assistance as needed.
• Contributes to own team/ closely related teams through quality and accuracy of own output.
• Conveys information in a concise and professional manner.
• Ask effective questions and solicits feedback to understand needs.
• Anticipates future needs based on past transactions
• Ensure product registration is completed in a timely and accurate manner.
• Any other duty as assigned by supervisor.

Responsibilities:

• Ensure all quality systems are in compliance with Abbott's corporate and division policy, procedures, applicable regulatory and standard.
• Responsible for document control and certifications (product quality related).
• Applies advanced knowledge of technical/ administrative skills to leverage the skills of others. To ensure all document change packages are processed timely and accurately.
• To conduct internal and external audits and maintained the audits schedule. Responsible for compliance activities in the plant.
• Responsible for SAP changes and verification of recipes, inspection plan, etc.
• Develops an understanding of internal operations and how related teams interact to achieve results.
• Work is guided by operational and project objectives. Improves process efficiencies in support of objectives. Uses a variety of data analysis tools and methodologies. Applies independent judgment to solve systemic problems.
• Recommends actions and regularly exercises discretion with regards to key business processes within the team.
• Plans and oversees the daily activities of a team.
• Promotes collaboration and accountability to meet team goals. Maintains internal and/ or external customer relationships.
• Frequently interacts with subordinate supervisors and functional peer groups. Resolves problems requiring broad-based analysis.
• Presents problem analysis and recommends solutions in a creative and logical manner.
• Any other duties as assigned by supervisor.

Requirements:

• Bachelor of Science Degree in Food Science, Food Technology, Dairy Science or related discipline
• 1 to 3 years of relevant experience or equivalent combination of education and work experience preferred.
• Good leadership and problem-solving skill. Good communication and report writing skill.
• Project management skills or experience in project management is essential.
• Team player with imitative, drive, good communication skills and a strong command of written English.
• Proven problem-solving capability, customer focus and commitment to continuous. Knowledge of HACCP and ISO systems would be preferred.
• Working exposure and understanding of manufacturing process.
• Knowledge in food engineering, thermal heat processing and fluid flow characterization, as well as experience in a dairy/ nutritional industry, would be advantageous.

*Kindly note this position is based in Tuas

Position Summary

The incumbent will be responsible for overall management of the Quality Control (QC) Laboratory services and their related support teams. With extensive knowledge of compliance requirements relating to the QC function together with excellent verbal, written, and interpersonal communication skills the incumbent will need to be action-orientated, agile with respect to change management and a strong leader for the quality culture of the Laboratory and the site to achieve the site Quality Control operational objectives. Key accountabilities include:

• Lead, coach and develop a team of QC Managers, supervisors and their related laboratory teams ensuring that analytical (physical, chemical and microbiological) testing, data review activities and Laboratory equipment and systems on site comply with site Standard Operating Procedures (SOPs) and are performed in a safe and reliable manner to support manufacturing operations at the site and across all shifts.
• Ensure that the quality systems in the Laboratory are continually audited with new requirements implemented and all QC related operations comply with Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards (PQS).
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

Responsibilities:

• Responsible for developing and managing integrated Quality Systems and providing technical support and advice on Quality Control matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Development.
• Responsibility of setting up and implementing QC Laboratory quality systems and strategies for developing and implementing monitoring systems to collect, collate and present information on Quality Control Laboratory for performance management and bench marking. This includes review and approval of Standard Operating Procedures (SOPs) and periodic review processes.
• Responsibility for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
• Plan and track Quality Control objectives, timelines, priorities, and resources.
• Develop, write and present business cases for equipment, staff resources and service developments.
• Manage and ensure the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements so as to provide accurate test results for correct GMP usage decisions.
• Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
• Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed).
• Ensure that the laboratory equipment are qualified to meet regulatory standards, well maintained and in good working order.
• Work closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
• Manage and provide oversight of the strategy and execution of Analytical Method Transfer Exercise (AMTE) from other Pfizer sites and Centre functions for new products introduced to the site. This involves the development / validation / verfication of new /existing analytical methods for testing starting materials, process intermediates, APIs and plant cleaning samples.
• Lead and/or contribute to the implementation of the site and corporate projects in line with specifications and budget allocation.
• Promote use of Right First Time (RFT) methodologies and root cause analysis tools for analytical trouble shooting, safety and Continuous Improvement Projects (CIP). Using Statistical Process Control (SPC) methodologies for improving efficiencies and cost.
• Ensure the product stability programs are managed and testing data (including stability data) is reported for Annual Product Review Reports (APRRs) and regulatory filing in a timely manner.
• Ensure laboratory automation is functional at all times and supports laboratory efficiency.
• Support, promote and demonstrate Pfizer Global Supply (PGS) vision, values and leader behaviors.
• Manage, develop, and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.
• Uphold Pfizer's code of conduct and values.
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
• Collaborate with cross-functional teams to drive flawless execution.
• Fulfil requirements of a first line leader (FLL) as described in site procedure that includes (but is not limited to) the below:
• Engage and inspire team on performance expectations and coach the team to meet expectations using Coaching Skills principles
• Effectively monitor the actions of team members. Ensure presence in the GMP work area to observe work activity and practices.
• Be available for direct report(s) for real time escalation of any concerns or support needs
• Be accountable for Good Data Management and Data Integrity understanding and performance of the team
• Be a role model to support a positive compliance culture
• Be vigilant for potential actions or behaviour that could result in breaches of GMP compliance or Data Integrity principles

Job Related Requirements:

• Effective problem solving skills.
• Demonstrated leadership, management and customer service skills.
• Excellent verbal, written and interpersonal communication and presentation skills.
• Demonstrated ability to interact effectively with senior management, auditors and regulators.
• Strong knowledge of analytical chemistry, analytical method validation, instrumentation, laboratory automation and production processes.
• Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories.
• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment, experience in Empower software.
• Knowledge of six sigma, lean labs and standard work practices.
• Possess a can-do / pride to succeed attitude and be a positive influencer/role model.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Education

Bachelor or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy, Pharmaceutical Sciences or Microbiology or a related science.

Experience

• Minimum 8-10 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable.
• Minimum 5 years in a leadership/supervisory position of professional staff previously, or demonstrated capability to successfully lead large teams.
• Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories.
• Experience in an API manufacturing plant is preferred.
• Effectively communicate through written and oral means, demonstrated ability to interact effectively with senior management, auditors and regulators.

The incumbent will have the following core competencies:

• Project Management skills
• Team Leadership skills
• Communication skills
• Analytical skills
• OPEX skills

SR Quality / Quality Lead/ Supervisor (QAQC)

Location: Penjuru Place (shuttle bus provided)

Monday - Friday 8am - 5.30pm

The Quality Lead/ Supervisor is responsible for ensuring timely and effective implementation of the company's policies, procedures, and standards involved in assuring the quality of manufactured products and customer satisfaction, as well as for conducting quality control activities. The Quality Supervisor strives to ensure the facility adheres to quality licenses, standards and certifications.

A successful candidate will collaborate closely with functional areas such as Manufacturing, Procurement, Mfg. Engineering, Sustaining Engineering, Product Lines, R&M and Geozones regularly as well as presenting to internal teams plans and updates.

Job Responsibilities:

• Supervise and lead 4 Quality Control Inspectors and liaise with internal & external stakeholders.
• Maintain site Quality Management System.
• Update QMS records and maintain all necessary documentation and certificates.
• Responsible for following management of change as processes and procedures are updated as per QMS requirements.
• Perform regular process audits in Manufacturing areas and functional areas, including technical work instructions, processes, procedures, and competence and ensure compliance.
• Generate CARs related to any deficiencies and track them to completion.
• Keep competency records up-to-date.
• Conduct training related to QMS, procedures, WIs, others.
• Actively participate in Contract Reviews.
• Develop customer QCP Plans. Ensure contractual requirements are built into Quality Control plans.
• Actively participate in Pre-Production meetings.
• Coordinate Client visits, and audits and constant communication to demonstrate our commitment and promote the Corporate Quality Management System.
• Drive action trackers to completion, related to customer audits, manufacturing reviews or qualification process.
• Coordinate TPIs per customer QCPs, and per production schedule. Ensure documentation meet requirements.
• Review/release WOs from a Quality point of view.
• CPARs/NCRs/COPQ; monitor performance/trends, data analysis, and evaluate the effectiveness of corrective actions to ensure that the required improvements are sustained. Actively participate in RCA. Monitor/track other Quality KPIs.
• Coordinate with product design engineers and manufacturing engineers the requirements in the quality plans and inspection and test plans to be aligned with their engineering design criteria, production schedules and customer requirements.
• Coordinate quality assurance plans for new PNs/product introductions.
• Review and approval purchased materials/products mill test certificates if it complies with the required company specifications and/or applicable industry standards prior to acceptance and use.
• Ensure quality control inspection and testing activities are performed in accordance with Global MFG QMS, customer QCPs/Inspection matrices, and/or local procedires and work instructions.
• Manage non-conformance process in accordance with Global MFG QMS.
• Identify a minimum of two continuous improvement projects per year to lead and complete with measurable improvement to the business in terms of margin, quality, etc
• Any other delegated responsibilities as instructed by his direct supervisor within the timeframe specified safely and efficiently to meet business requirements, provided the instruction is reasonable and you are capable and deemed competent to fulfil these.

Job Requirements:

• 5 to 8 years of experience with ISO-9001
• Minimum 5 years of experience in QA/QC role in the manufacturing environment
• Excellent written, reading, and oral communication in English
• Computer literate and familiar with Microsoft Office software at a minimum
• Fast learner, results-oriented and independent with strong interpersonal skills
• Possess strong customer service skills, i.e. listening, follow-through, and willingness to help
• Certified Auditor
• Ability to read engineering drawings
• Ability to interpret MTCs (Material Test Certificates) against the Company specifications
• Skilled at data mining (Excel Pivot Tables, other Excel tools)

Preferred

• Lean / Six Sigma experience
• Certified Lead Auditor
• Root Cause Analysis implementation experience
• Power BI dashboards.

The primary purposes of this role includes:

• Drive PGCS Quality programs and policies compliance across site, by partnership with functional stakeholders.
• Key contributor/promoter to the advancement of Quality function across the sites; creating and driving critical/key business objectives in line with supporting/partnering with Operations, Supply Chain functions etc.
• Lead incident management and resolution and champion customer quality across Singapore. Site lead for Quality and Food safety crisis mgmt.
• Lead the implementation of the Singapore Quality Strategy including communication, project management and roll out activities.
• Lead continuous improvement culture/productivity initiatives to support site BPI process, demonstrating best practices to implement all quality improvements
• Drive, support and champion KPIs, key Quality metrics, etc.
• Act as a business partner to other functions whilst championing Quality, to ensure an extended and consistent quality focus.
• Be a key member of the Site Leadership team and value add in driving functional and site agenda.
• Support and provide strategic guidance around NPIs, validation, Total Quality System, Compliance, Capital investment, etc.
• Partnership with other functions ensuring change control risk assessment and validation in place for Network capacity projects and other key projects and significant changes.
• Financial Management; Budgetary and AOP responsibilities/input.
• Compliance; drive partnership with other functions through the Quality team to achieve key business goals for the control environment. Compliance with all regulations and 3rd party auditing requirements.
• Provide strategic quality leadership to the extended Quality Team
• Organisation design & sustainability of a highly effective team with appropriate succession plan. Encourage, manage & promote people-related activities/processes, partnering with HR
• Develop capability, personal growth and career development for direct reports, support these activities with DRs’ associated teams.
• Play in instrumental role in developing the overall team capability, supporting and aligning with overall plant culture.
• Ensure the smooth transition of new products to the Singapore facilities.
• Manage the complexity of additional materials, packaging and concentrate components from a quality perspective as portfolio expands
• Support and implement PGCS SC global quality initiatives
• Systems improvements (including IT systems) in terms of Processing, GMP, Product Safety, Disposition and Traceability.
• A requirement of the role is that you must adhere to all PepsiCo Health & Safety requirements.
• Any other ad hoc duties and projects as assigned

PRE-REQUISITES

• Bachelor’s Degree in Science, Food Technology, Chemistry or any other related discipline
• Minimum 7 years of relevant experience as a supervisor in operating Laboratory environment, manufacturing concern/MNC
• Ability to manage sennior stakeholders and leadershup team members
• Experience in People Management and prior supervisory skill
• Possess knowledge of and experience in GLP, HPLC / GC operation, SAP QM module and LIMS management
• Strong leadership presence, ability to manage and co-ordinate with cross-functional teams on investigation analysis, troubleshooting and issues resolution
• Knowledge of food safety quality standards such as HACCP and FSSC 22000
• Ability to lead change and drive behaviours
• Ability to organize and manage multiple priorities in high-pressure work environment
• Strong collaboration and influencing skills
• Excellent communication and interpersonal skills, both verbal and written with ability to clearly articulate ideas and proposals to all levels of the organization
• Positive and Can-do Attitude
• Willing to stretch and take additional responsibilities when needed
• Lead by example to others

We regret that only shortlisted candidate will be notified.

Purpose

• To lead and manage Site validation activities (as assigned) to ensure that validations are in compliance with company procedures, regulatory requirements, and cGMP expectations.
• To provide QA compliance oversight over IT and Technical Services (as assigned)

Key Responsibilities Area

Ensure site validation activities are compliant with Site procedures, regulatory requirements, and cGMP expectations:

• Author and maintain the quality system SOPs for validation.
• Define validation approach that is technically sound and are compliant.
• Author Validation Plans and Reports, including Continuous Validation Plan
• Review and approve validation deliverables
• Provide solutions to achieve validation requirements
• Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule
• Drive efficiency, improvement and robustness in site validation systems and processes.
• Be the link with Global Validation for technical information, and standards roll out
• Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems
• Assess impact to validation for incidents/deviations and ensure appropriate CAPAs are in-place to resolve issues and prevent recurrence.
• Perform Periodic Review and prepare the review report for systems and processes.
• Oversee Periodic requalification and Continued process verification to maintain the validated status of systems and processes.
• Conduct GSK internal audits and front as SME in external regulatory inspections.
• Provide support for all activities related to GPS (e.g. Tiers, Gemba, DMAIC etc) for continuous improvement.

Provide QA Oversight to IT operations in areas of:

• QA consultation to review and approve SOPs
• Review and approve changes, deviations and CAPAs

1. Provide QA compliance oversight to Technical Services

• Interact with TS personnel in day-to-day operations to ensure cGMP compliance
• Be the QA approver for TS activities including but not limited to LSOPs, Deviation/Event, CAPAs, Change Controls, and Quality Tag-Outs
• Pest control reports - Calibration & maintenance programs Pest control reports.

2. Interface with Internal & External stakeholders

• Effective interfaces with internal and external stakeholders to ensure effective communication with and cascades from Global functions.

3. EHS

• Comply with company requirements on EHS

Proposals & Recommendations

• Propose validation approach
• Propose areas of site validation improvement
• Identify potential compliance risk/ gaps and recommend improvement
• Identify improvement in quality processes.

Skills, Knowledge & Experience

• Min bachelor's degree in industrial biotechnology or engineering
• Min 2 years of experience in pharmaceutical industry
• Min 5 years of experience in quality assurance and validation.
• A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturing
• Good understanding of regulatory inspection requirement
• A good working knowledge of validation, preferably with hands-on experience
• Computer skills in MS Office and familiar with web-based e-learning resources
• Potential or developing project management skills.

#Li-GSK

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. ​

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.​

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Primary Function:

• Ensure that change control and validation activities are executed in a timely manner.

Key Responsibilities:

• Develop, execute and review validation protocols and related documentation in accordance with procedures and policies
• Support Failure Mode Effects Analysis (FMEA) for new installations or changes.
• Manage change control documentation in respective data management systems
• Perform root cause analysis and identify corrective and preventive actions in addressing quality events
• Support resolution of validation events and escalate concerns in a timely manner
• Support in equipment and process walkdowns
• Weekly, Monthly and Quarterly reporting as required for own business area
• Develop and execute business area improvement projects
• Develop training materials and conduct training
• Participate in internal and external audits
• Participate in division and site projects, improvement activities and technical sharing platforms
• Comply to all policies and standards
• Any other ad-hoc requests as assigned by the supervisor

Requirements:

• Bachelor's Degree in a Science or Engineering discipline
• Min 3 years of related experience in change control and validation in a manufacturing plant required, preferably in Food/Nutrition/Pharma industry
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Familiarity in developing SOPs and work flows
• Knowledge of problem-solving tools (e.g. 6M Analysis, Fishbone, 5 Whys, etc.).
• Familiarity with international and technical standards is a plus (ISO, FSSC etc)
• Proficient in Microsoft applications (Powerpoint, Word, Excel)
• Team player with initiative, drive, good communication skills and a strong command of written English
• Ability to think systematically and with analytical mindset
• Ability to do data analysis using Minitab, JMP is a plus
• Experience in manufacturing process design and equipment design or application is a plus

*Kindly note this position is based in Tuas.

Mission

Sanofi is preparing its future through an ambitious program named EVolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi Pasteur strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address vaccine business challenges. Digital will be one of the key topics to help EVF to reach its ambition. On top of it, Sanofi is also embarked with the ambition to leapfrog the competition through a digital acceleration program with the following vision: “Sanofi will fully integrate Digital capabilities & culture within its operations to boost business growth and profitability in 2025+”.

In this context, we are looking for Specialist II, Quality Operations for our new site based in Singapore.

Key Accountabilities

The mission described below, must be exercised in compliance with health, safety and environment of the site rules.

The Specialist II, Quality Operations will be responsible to partner with the GMP operations team to provide Quality oversight and advice for Quality on-the-floor and operations support to ensure the EVF Singapore GMP Quality operations meets Sanofi global Quality standard requirements and fulfil the applicable regulatory expectations. The Specialist II, Quality Operations shall be experienced in solving complex problems, and strong understanding of cGMP operations and well-versed in multiple Quality systems (including exception management, change controls, deviations/CAPAs and document management system).

The incumbent will partner closely with operational teams (e.g. manufacturing, facilities, Quality control and technical units) to ensure Quality, safety, reliability, efficiencies to support EVF Singapore GMP manufacturing operations.

During the Project Phase, the Specialist II, Quality Operations will participate in the following Engineering / Commissioning & Qualification activities:

Engineering / Commissioning & Qualification activities:

• Review and approval of engineering documents related to GMP operations.
• Support and provide inputs to Installation, Operational Qualification (IOQ) activities for equipment used in GMP operations.
• Review and approval of operational, as well as process related documents (e.g. work instructions, SOPs, batch records).
• Support the digital and automation infrastructure setup including Delta V recipe, MES workflows, other process equipment related systems, ERP module setup, etc.
• Ensure that Quality related operational procedures and infrastructures are successfully implemented in preparation for Engineering runs and PPQ runs at the EVF Singapore Site to support site operational readiness and success.

Provide GMP Quality support during PPQ runs:

• Responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials release, deviations, change controls and CAPAs) at EVF Singapore manufacturing facility.
• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations.
• Escalate significant Quality issues to Quality management in a timely manner.
• Champion Quality within the Operations team to establish an engrained Quality culture across the organization.

Working hours –

• Personnel shall be able to work office hours (weekdays) in Sanofi Site Office to support collaborations and meetings with stakeholders leading up to Engineering runs.
• Personnel shall be able to work 12 hours rotating shift (including day/night, and weekends) on site to support PPQ runs and Engineering runs, as required.
• Work from Home (hybrid) arrangements are subjected to discussion with Function Manager during the Project Phase.

During  Routine Operations, the Specialist II, Quality Operations shall:

• Be responsible to provide direct solid Quality advice to GMP operational teams to ensure compliance, reliability and efficiencies.
• Be accountable to ensure that Quality related operational procedures and infrastructures are successfully implemented to support EVF Singapore site operational and inspection readiness and success.
• Be responsible to provide direct QA oversight for all GMP operations (including on-the-floor Quality oversight, raw materials release, deviations, change controls and CAPAs) at EVF Singapore manufacturing facility.
• Represent Quality to triage, resolve on-the-floor operations issues, and participate in root cause investigations.
• Escalate significant Quality issues to Quality management in a timely manner.
• Champion Quality within the Operations team to establish an engrained Quality culture across the organization.
• Lead and support the site driven QA continuous improvement initiatives/activities during the routine operational phase.
• Participate in regulatory inspections and interact directly with regulatory inspectors (as applicable).
• Lead and support QA Operations related trainings and coaching for the Quality organization.
• Contribute to reach the EVF Quality manufacturing 4.0 ambition through a Quality plan.

Working hours –

• Personnel must be able to work 12 hours rotating shift (including day/night, and weekends) on site to support production activities.

Education and experience

• Bachelor’s or Master’s Degree in Sciences, engineering or other related technical field.
• Minimum of 5 years of relevant experiences preferably in Manufacturing, Validation, Engineering, Quality in the pharmaceutical or biotechnology industry (preferably in vaccines and/or biologics).

Key technical competencies and soft skills:

• Manufacturing 4.0 mindset (such as Agile methodology)
• Expert Knowledge of regulations and standards of the pharmaceutical industry, Global Quality policies and Data Integrity Requirements.
• Solid manufacturing process technical knowledge.
• Broad understanding of QA Operations (from an end-to-end perspective).
• Strong interpersonal skills to establish the partnerships necessary for the development of an engrained Quality culture and the correct execution in transverse.
• Ability to work independently and make quick, effective decisions under pressure.
• Discipline and assertiveness in the decision-making and execution of digital manufacturing strategy.
• Familiarity with electronic batch record (MES) and related review processes.
• Familiarity with batch release and disposition process, preferably using the SAP system.
• Proficient in QMS and Quality Risk Management Principles.
• Excellent verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management and execution levels.
• Experience in facility start-ups will be advantageous.
• Good understanding of risk-based decision framework.
• Familiar with Digital 4.0 concepts and potential applications in Quality.