Total 14 sales specialist job vacancies in Quality Assurance / Control category in D14 Geylang, Eunos

Overview:

The QC Specialist is responsible for timely review, confirmation, disposition, and resolution of nonconforming materials in accordance to established NC process to meet quality targets. You will investigate instrument complaints, pursue containment action, root cause identification and corrective actions. You will also execute continual improvement initiatives to meet organization objectives, support IQC process and participate in Supplier Improvement Initiative and will also support and execute installation qualification and maintenance of QC ancillary equipment.

How You’ll Make an Impact:

• Responsible to verify and confirm supplier material defects in daily walk-the-line. Ensure defects are adequately investigated with supporting reports.
• Drive cross functional teams in nonconformance investigation. Review Quality Notification activities for timely defect disposition. Responsible to ensure all QN tasks are adequately completed before closure.
• Investigate instrument complaint, established immediate containment, identify root cause and implement correct action.
• Engage cross functional team to improve QC test First Pass Yield. Participate in continuous improvement initiatives.
• Support IQC process with specification review and Quality Inspection Plan set up.
• Support QC Lab equipment validation, calibration, and preventive maintenance.
• Generate weekly, monthly QN reports for trend analysis and presentation in scheduled Management Review meeting. Drive QN closure to meet aging and defect cost targets
• Participate in Product Transfer Initiative – New or existing products from other sites. Review QC test procedure for adequacy

What You Bring:

• Bachelor’s degree in Mechanical or Electrical Engineering or Diploma in Mechanical or Electrical Engineering with minimum 5 years of Quality Engineering experience or demonstrated competency.
• 1 - 3 years of manufacturing quality assurance / control /engineering experience in a regulated environment preferred
• Knowledge of ISO 13485 MDSAP requirements. Lead Auditor preferred
• Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
• Possesses excellent problem-solving, interpersonal, communication and leadership skills.
• Must be self-motivated, result oriented with minimal supervision.
• Hand-on experience of statistical tools application. Lean/ Six Sigma Green Belt preferred.
• Experience with ERP systems a plus, SAP preferred.
• While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Overview:

The QC Specialist is responsible for timely review, confirmation, disposition, and resolution of nonconforming materials in accordance to established NC process to meet quality targets. You will investigate instrument complaints, pursue containment action, root cause identification and corrective actions. You will also execute continual improvement initiatives to meet organization objectives, support IQC process and participate in Supplier Improvement Initiative and will also support and execute installation qualification and maintenance of QC ancillary equipment.

How You’ll Make an Impact:

• Responsible to verify and confirm supplier material defects in daily walk-the-line. Ensure defects are adequately investigated with supporting reports.
• Drive cross functional teams in nonconformance investigation. Review Quality Notification activities for timely defect disposition. Responsible to ensure all QN tasks are adequately completed before closure.
• Investigate instrument complaint, established immediate containment, identify root cause and implement correct action.
• Engage cross functional team to improve QC test First Pass Yield. Participate in continuous improvement initiatives.
• Support IQC process with specification review and Quality Inspection Plan set up.
• Support QC Lab equipment validation, calibration, and preventive maintenance.
• Generate weekly, monthly QN reports for trend analysis and presentation in scheduled Management Review meeting. Drive QN closure to meet aging and defect cost targets
• Participate in Product Transfer Initiative – New or existing products from other sites. Review QC test procedure for adequacy

What You Bring:

• Bachelor’s degree in Mechanical or Electrical Engineering or Diploma in Mechanical or Electrical Engineering with minimum 5 years of Quality Engineering experience or demonstrated competency.
• 1 - 3 years of manufacturing quality assurance / control /engineering experience in a regulated environment preferred
• Knowledge of ISO 13485 MDSAP requirements. Lead Auditor preferred
• Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
• Possesses excellent problem-solving, interpersonal, communication and leadership skills.
• Must be self-motivated, result oriented with minimal supervision.
• Hand-on experience of statistical tools application. Lean/ Six Sigma Green Belt preferred.
• Experience with ERP systems a plus, SAP preferred.
• While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Job Title

Control IT Software Specialist

Job Description:

Do you like to take an extra step, analyzing the root cause of a failed software component or interface, and providing solutions for the cause?

Vanderlande understands the complexities associated with a successful airport and parcel operation and delivers future-proof logistic process automation. These automation systems are composed of many Electromechanical, IT, and control components that require expert knowledge to support.

As an IT System Control Specialist, you will analyze and assist in servicing baggage handling system control software. You are responsible for helping the operation and maintenance team find and resolve system issues, researching solutions, and proposing changes to the system. You will have frequent contact with internal and external customers and third-party contractors.

As an IT System Control Specialist, you have a strong affinity with Oracle data administrator and Java-oriented software combined with the Linux platform they run on.

Key responsibilities:

· Identify problems and perform root cause analysis of upper-level control software of Vanderlande baggage handling system, in close collaboration with other teams.

· Review system and application logs to trace issues and gather information for analysis.

· Develop and maintain customer-specific validation test processes and reports for change control log.

· Continuously monitor IT infrastructure, application, and material handling application environment.

· Triage all events reported and maintain incident reports.

· Planning and delivering preventive maintenance tasks & assigned change tasks (back-ups, patch execution, etc.)

· Have a systematic way of troubleshooting a problem.

· Advise the customer on actions to minimize equipment downtime.

· Take proactive measures based on own insight, lifecycle plans, or preventive maintenance plans.

Qualifications:

· Bachelor’s degree in computer science engineering, information technology, information systems, mathematics or a related field of study.

· Preferably you have a good understanding of IT service management practices (ITIL v3/v4)

· Affinity with IT and Industrial Automation and interest in logistic processes.

· 5 years of relevant working experience in industrial systems.

· Hands-on experience with Oracle SQL and JAVA software development is preferred.

· Hands-on experience with LINUX and network communications is preferred.

· Basic knowledge of IT infrastructure and software development

· Basic knowledge of testing methodologies and troubleshooting techniques

· Good communication skills in English.

· Assertive team player and proactive.

· May have to work after hours and weekends as the operation runs 24/7.

• Main contact person for the third-party manufacturing and oversee the TPM operation/process.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support to ensure that all quality goals are met, and all practices and procedures comply with company policies, GMP principles and applicable regulations for the quality areas.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Manage TPM documents, quality agreement, FMEA, ASL and TPM scorecard/KPI.
• Review, evaluate and approve all major deviations and determine the need for a corrective action. Document the deviation in the Trackwise system and perform product impact analyses.
• Review, evaluate and approve all TPM change requests for process related, commodity, raw material, SCN, QC and facilities. Initiate global change in the Trackwise system.
• Provide a constant review on the manufacturing process, equipment and facilities to assure compliance with procedures, specifications, and policies.
• Write, review and approve annual product report/product quality report.
• Actively involved in Pre-campaign activities, Post-campaign review (Track & trending program)
• Perform timely lot disposition in the SAP and LRMS/LotSmart system to meet shipment timeline and demands.
• Prepare CoA, CoC and release package for drug substance.
• Coordination of regulatory requests, including country submission, dossier review, GMP Renewal Program.

About You:

● Bachelor Degree with at least 5 years' experiences in pharmaceutical or biotech facility preferably familiar with Quality Compliance, QA Third-party manufacturing oversight and/or QA Operations.

● Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility

● Relevant QA background from pharma or biotech environment is preferred

● Familiar with Health Authorities standards (e.g., FDA CFR and EU)

● Must be team player, meticulous, strong communication, analytical and organizational skills

Responsibilities:

• Provide Quality oversight to Cleaning, Standardization and Optimization projects.
• Review and approve acceptance tests/reports in accordance with relevant policies, standards, procedures, and guidelines timely.
• Review and approve as needed, qualification/validation exceptions, deviation and/or investigations encountered during acceptance test execution representing Quality.
• Collaborate with multi functions to arrange, plan, and ensure smooth running of the execution activities.
• Any other tasks as and when assigned by the supervisor.
• Support other technical changes and duties as required.

About You:

• Bachelor of Science/Engineering or higher in a scientific or engineering discipline
• Possess minimum 5 years of qualification/validation experience.
• Must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills.
• Must be team player, meticulous, strong communication, analytical and organizational skills
• Knowledge and ensure compliance with cGMP and safety regulations;
• Liaise with stakeholders to ensure proper implementation
• Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams

Responsibilities:

● Providing support to training team

● Providing support to develop training materials and presentations

● Providing support to the training team in system migration activities

● Manages the day-to-day operations of site-wide learning training credit in LMS system

● Check and review training records meet the data integrity criteria

● Liaises with employees to ensure training records are complete

● Maintaining and organizing files and training records

● Support internal and External documentation such as ISO readiness and certification

● Perform any duties assigned by Supervisor/Manager

About You:

● ITE/Diploma/Bachelor in Engineering, Sciences, Business, Information Systems or equivalent. 1-2 years of experience in documentation DMS/ QA in pharma or biotech facility.

● Proven work experience as a Document Controller or similar role

● Knowledge of Electronic Document Management Systems (EDMS)

● Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility

● Good interpersonal, communication and presentation skills.

● Must be a self-starter, fast learner, curious with strong analytical and organizational skills

● Self-motivated and willingness to learn

● Reliable, Meticulous and Responsible

● Proficient in Microsoft Office and other relevant software

● Able to work independently and as part of a team

● Strong organizational and communication skills

Notes :

Full-time/Part-time options are available

Responsibilities:

Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times.

The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and responsible to ensure highest quality and compliance of released batches.

Responsibilities:

• Ensure that products manufactured meet approved company policies, processes and procedures
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
• Participate and support new product introduction, operation excellence projects and other tasks as assigned by management

About You:

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses
• Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics
• Minimum of 2 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
• Experience in SAP, Trackwise are preferred
• Ability to quickly know products and processes in order to assess quality issues
• Committed to quality and maintain a high standard of work at all times
• Demonstrates the highest levels of integrity and a strong work ethic
• Good knowledge of GxP requirements and regulations
• Good planning and scheduling skills
• Good communication and interpersonal skills both verbal and written
• Must be team player, meticulous, strong analytical and organizational skills

Only shortlisted candidates will be notified.

12 months. Subject to extension/conversion based on performance.

• Main contact person for the third-party manufacturing and oversee the TPM operation/process.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support to ensure that all quality goals are met, and all practices and procedures comply with company policies, GMP principles and applicable regulations for the quality areas.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Manage TPM documents, quality agreement, FMEA, ASL and TPM scorecard/KPI.
• Review, evaluate and approve all major deviations and determine the need for a corrective action. Document the deviation in the Trackwise system and perform product impact analyses.
• Review, evaluate and approve all TPM change requests for process related, commodity, raw material, SCN, QC and facilities. Initiate global change in the Trackwise system.
• Provide a constant review on the manufacturing process, equipment and facilities to assure compliance with procedures, specifications, and policies.
• Write, review and approve annual product report/product quality report.
• Actively involved in Pre-campaign activities, Post-campaign review (Track & trending program)
• Perform timely lot disposition in the SAP and LRMS/LotSmart system to meet shipment timeline and demands.
• Prepare CoA, CoC and release package for drug substance.
• Coordination of regulatory requests, including country submission, dossier review, GMP Renewal Program.

About You:

● Bachelor Degree with at least 5 years' experiences in pharmaceutical or biotech facility preferably familiar with Quality Compliance, QA Third-party manufacturing oversight and/or QA Operations.

● Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility

● Relevant QA background from pharma or biotech environment is preferred

● Familiar with Health Authorities standards (e.g., FDA CFR and EU)

● Must be team player, meticulous, strong communication, analytical and organizational skills

You are responsible for driving the resolution for product quality issues through collaboration with production, manufacturing engineering and supplier quality teams. You would monitor process data and initiate improvements to meet organization objectives, ISO 13485 (MDSAP) and applicable regulatory requirements. You will also support QC Instrument Test on reagent management and procedural update to meet delivery commitment.

How You’ll Make an Impact:

• Initiate internal and/or supplier non-conformances review meetings to ensure timely disposition and closure of QNs.
• Proactively monitor QC test yield, collaborate with Engineering and Manufacturing to identify and implement improvements to manufacturing processes or QC test procedures.
• Attend Complaint Review meeting. Participate in failure analysis of Customer Returned Instrument to verify complaint and identify Product Quality improvement opportunities.
• Establish process Quality Control criteria and provide training to QC Technicians as needed.
• Monitor process, product quality and performance trend. Implement effective improvement initiatives to meet organization KPI targets.
• Manage QC laboratory activities to support production. Maintain a validated QC laboratory including equipment trouble shooting if required. Identify opportunities to improve laboratory practices.
• Participate and review Site Process Validation activities to ensure Quality control adequacy.
• Generate weekly, monthly Quality performance reports for trend analysis and presentation in scheduled Management Review meeting.

What You Bring:

While this list of qualifications may help an employee to succeed in this position, capable candidates may have a wide range of backgrounds or skills. If you have experience that aligns with the responsibilities of this role, we encourage you to apply.

• Bachelor’s Degree in Chemistry, Bio-Chemistry or Life Science.
• Min 3years of manufacturing quality control in a regulated environment with exposure to QC laboratory process is preferred.
• Experience in Process Validation, Non-conforming Process, Customer Complaint investigation.
• Experience with ERP systems a plus, SAP preferred.
• Knowledge of MDSAP and/or ISO13485 requirements. Preferable lead auditor certified.
• Knowledge of Good Laboratory Practice (GLP). Handling and disposal of Bio-Hazard materials.
• Hand-on experience of statistical tools application. Lean/ Six Sigma Green Belt preferred.
• Possesses excellent problem-solving, interpersonal, communication and leadership skills.
• Must be self-motivated, result oriented with minimal supervision.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

Benefits: Bio-Rad's biggest asset is our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle. We’re proud to offer comprehensive medical plans and insurance, flexible benefits, wellness programs, extensive learning and development opportunities and more.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Quality Assurance Specialist (x20) - Call Center exp

Permanent/ Direct Employment

Location: Central, Singapore

Duties & Responsibilities:

• Perform daily auditing on the internal system
• Provide analysis of errors and feedback to the respective team;
• Work with training team to align policy understanding of QA and labelers;
• Provide support on Policy/Quality related questions on an ad-hoc basis;
• Responsible for guiding new joiners in order to achieve ramp-up target;
• Work closely with the business team in order to provide feedback on quality;
• Identify potential errors in policy and correct them in time;
• Conduct quality meetings with the team to analyze errors;

Requirements:

• Bachelor's Degree or equivalent education/experience, advanced degree is preferred;
• Minimum 1-year working experience in text editing work with good reading and writing skills, be able to distinguish sentence type, text type, and writing styles;
• Experience in AI model labeling/ journalist/news or social media industries will be an added advantage;
• Strong attention to detail and ability to work independently and consistently;
• Possesses clear logic and good structure in information generation;
• Be capable of sorting, analyzing, and re-organizing authentic information from online sources;
• Be capable of identifying contents that can obviously or potentially cause user damage.
• Be fluent in the language and understand the nuances of the target language, having a good sense of emerging trends, news, slang, and emojis of social media.

Thank you!

EA Licence No: 19C9807

Registration No: R1114636 (Manalo Don Don Briones)

Responsibilities:

• Provide Quality oversight to equipment/system qualification, automation qualification (PCS/BAS) and cleaning validation
• Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely
• Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality
• Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
• Participate in site Validation Maintenance Program
• Any other tasks as and when assigned by supervisor
• Support other technical changes and duties as require

About You:

• Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science
• At least 5 years qualification/validation experience
• Possess process automation experience will be the additional benefit to be considered
• Communicate well, self driven, motivated and able to work well with others
• Based in Tuas

Job Type: Contract

Contract length: 8 months

Experience:

• qualification/validation: 5 years (Preferred)

Responsibilites

• Act as APAC regulatory point of contact, providing production sites and local entities with regulatory support and guidance
• Stay updated about all relevant laws, rules and regulations affecting global trade activities within the industry
• Anticipate and manage the regulatory compliance and technical standards in relation with local regulations and trade associations in APAC markets
• Monitor and analyze key regulatory policy trends in APAC markets to support strategic business decisions
• Engage with key stakeholders in external regulatory forums and industry bodies
• Manage technical registrations in accordance with local regulatory needs
• Analyze technical data and identify the best technological solutions
• Creation of technical data sheets (product engineering data) tailored to specific customer requests
• Support other Group functions with specialized technical knowledge

Requirements

• Professional experience in the role or similar:
• More than 3 years Management experience with similar dimensions., specific experience in b2b market.
• Highest Education Level*: Degree in Engineering or R&D

Responsibilities:

● Coordinate with suppliers and verify supplier quality standards are in accordance to the

requirements

● Track and qualify or disqualify suppliers according to standards

● Liaise with suppliers or support the senior supplier qual specialist to support documentation

compilation and GMP/GDP review per procedural requirements

● Monitor supplier quality performance by tracking product defects, delivery failures and other

recorded incidents involving the supplier's failure to meet requirements

● Support document centre activities

● Maintain accurate quality records, certifications and database records

● Compiles Supplier Quality Reports for Management

● Support regular and routine supplier quality audits to ensure compliance with regulatory

standards, waste elimination and continuous improvement

● Any other task as assigned by Supervisor/Manager

● Based in Tuas

About You:

● Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably

familiar with biopharma QA Operations.

● Possess GMP systems knowledge with Supplier Quality Management concept

● Knowledge of quality management system, supplier quality management, current Good

Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or

biotech facility

● Must be team player, meticulous, strong analytical and organizational skills

● Enthusiastic, interested and committed to support Quality systems processes and potential

participation in new product introduction activities

Responsibilities:

Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times.

The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and responsible to ensure highest quality and compliance of released batches.

Responsibilities:

• Ensure that products manufactured meet approved company policies, processes and procedures
• Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities.
• Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out.
• Release incoming material, process, and product batches.
• Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product.
• Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies.
• Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
• Participate and support new product introduction, operation excellence projects and other tasks as assigned by management

About You:

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses
• Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics
• Minimum of 2 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.
• Experience in SAP, Trackwise are preferred
• Ability to quickly know products and processes in order to assess quality issues
• Committed to quality and maintain a high standard of work at all times
• Demonstrates the highest levels of integrity and a strong work ethic
• Good knowledge of GxP requirements and regulations
• Good planning and scheduling skills
• Good communication and interpersonal skills both verbal and written
• Must be team player, meticulous, strong analytical and organizational skills

Only shortlisted candidates will be notified.

12 months. Subject to extension/conversion based on performance.