Total 32 Quality Assurance / Control job vacancies

Job Description

80%

• Perform loading and Operating of Autoclave
• Responsible for MFR (Manufacturing Formulation Record)/SOP creation and revision
• Perform monitoring for process and equipment performance during operation as per SOP/MFR, identify and report if there’s any atypical events
• Support investigation to event and deviation
• Interface with other departments to resolve issues related to daily operations
• Actively support transfer of new processes and commission/validation of new projects
• Actively support Change Control management

10%

The individual will manage equipment and support facility related projects by
• Support routine safety and GMP walk down and responding to findings (If required)
• Support execution of Corrective/Preventive actions which identified (If required)

• Support change control activities which assigned (If required)
• Act as a SME for investigation and solution
• Liaise with other department for Corrective/Preventive actions which identified
• Support shift change/handover activities

10%

Staff Technical Training and Development
• Meet and maintain training requirements
• Complete assigned training on time
• Provide technical training for area personnel
• Provide input on training material development
• Deputize for shift supervisor’s activities
• Provide annual performance self-assessment on development plan

• Responsibility to adhere to any applicable EHS requirements.
• Commitment to a fair and respectful relationship to others and behavior in accordance with Code of Conduct.

Education and Experience Requirements

• Min Degree in Biomedical Sciences / Chemical Engineering or related with up to three years of relevant experience in the biotechnology, pharmaceutical industry
• Demonstrate commitment to cGMP, EHS compliance aspects of clean-room and plant operation
• Able to take initiative with good problem solving skills
• Excellent team player with hands-on attitude
• Able to work on rotating shifts
• Ability to lift, pull or push equipment requiring up to 20kg
• Able to climb ladders and work on platforms
• Able to perform confine space entrant/attendant/Supervisor/Assessor (If required)

• Ability to read/understand Safety Data Sheet (SDS) and handle chemicals as per SOP

• Able to monitor and analyze processing parameters to identify atypical trends
• Able to support Continuous Improvement Projects
• Able to perform as a subject matter expert for equipment and/or systems

If you are interested in any of the positions, do kindly drop your most updated resume to leonleong@recruitexpress.com.sg

Thank You.

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

As a Senior/Staff Firmware Test Engineer in the Solid State Drive (SSD) group at Micron Technology, you will help ensure our SSD products have world-class performance and reliability. This outstanding opportunity allows you to collaborate with skilled experts to build flawless SSD firmware for enterprise and automotive markets. Your ambition and proven expertise will help us develop innovative solutions and advance technology.

Responsibilities

• Build comprehensive firmware verification plans for various firmware features.

• Develop white/ grey-box, known, and closed system testing methods to verify and validate firmware products.

• Analyze failures from weekly regressions and perform root-cause analysis, requiring deep SSD domain expertise.

• Manage test development, test deployment, test automation, and reporting activities.

• Communicate challenges, solutions, and mitigation plans to cross-functional teams and management with clear and effective communication of both technical and non-technical topics.

• Participate in code reviews and guide the team to ensure comprehensive coverage and accurate architectural build.

• Establish strong working relationships with firmware development engineers to improve code quality.

• Lead a team of technical people, as required.

Qualifications

• B.Sc. in Electrical Engineering, Computer Engineering, or Computer Science

• 6-8 years of pertinent experience in SSD firmware test development

• Comprehensive understanding and substantial experience in SSD firmware testing and Python programming

• Deep understanding of storage industry protocols such as PCIe/ NVMe

• Familiarity with Agile development, GIT development flow and branch management.

• Experience with automated build, continuous integration, and test automation systems

• Highly organized, creative, motivated, and passionate about achieving results

• Ability to work on complex tasks independently with minimal supervision

• Demonstrated leadership abilities and the capability to mentor less experienced engineers

• Excellent problem-solving and analytical skills

• Strong interpersonal and communication skills, and a great teammate

• Candidates with 2-3 years of experience but strong Python programming skills and test development experience may be considered for entry-level positions

As a Senior/Staff Firmware Test Engineer in the Solid State Drive (SSD) group at Micron Technology, you will help ensure our SSD products have world-class performance and reliability. This outstanding opportunity allows you to collaborate with skilled experts to build flawless SSD firmware for enterprise and automotive markets. Your ambition and proven expertise will help us develop innovative solutions and advance technology.

Responsibilities

• Build comprehensive firmware verification plans for various firmware features.

• Develop white/ grey-box, known, and closed system testing methods to verify and validate firmware products.

• Analyze failures from weekly regressions and perform root-cause analysis, requiring deep SSD domain expertise.

• Manage test development, test deployment, test automation, and reporting activities.

• Communicate challenges, solutions, and mitigation plans to cross-functional teams and management with clear and effective communication of both technical and non-technical topics.

• Participate in code reviews and guide the team to ensure comprehensive coverage and accurate architectural build.

• Establish strong working relationships with firmware development engineers to improve code quality.

• Lead a team of technical people, as required.

Qualifications

• B.Sc. in Electrical Engineering, Computer Engineering, or Computer Science

• 6-8 years of pertinent experience in SSD firmware test development

• Comprehensive understanding and substantial experience in SSD firmware testing and Python programming

• Deep understanding of storage industry protocols such as PCIe/ NVMe

• Familiarity with Agile development, GIT development flow and branch management.

• Experience with automated build, continuous integration, and test automation systems

• Highly organized, creative, motivated, and passionate about achieving results

• Ability to work on complex tasks independently with minimal supervision

• Demonstrated leadership abilities and the capability to mentor less experienced engineers

• Excellent problem-solving and analytical skills

• Strong interpersonal and communication skills, and a great teammate

1. Perform daily periodic checks of Central Kitchen to ensure compliance to in-house GMP/GHP standards, SOP, Product Specifications, etc.

2. Conduct random checks on incoming raw materials, and perform product cutting on raw materials to ensure goods received are within in-house specifications.

3. Ensure Process Verification and Validation exercise are completed (i.e. SOP/CCP verification, new product launch process observation, monthly facility checks, monthly traceability exercise, finished goods shelf-life verification, etc.)

4. Conduct investigations on product/process non-conformance (on-line and customer complaints) and follow-up on proposed corrective/preventive measures to ensure effectiveness.

5. Promptly follow-up with contractors (chemical/pest control) during routine servicing to ensure work orders are conducted as per contract.

6. Participate and engage in quality system implementation (audit activities by regulatory/certification bodies and customers).

7. Conduct data/trend analysis on non-conformity of raw material/finished goods, pest reporting statistics, monthly production and facility check statistics, etc. for process and quality improvement.

8. Ensure analysis of food products via microbiological and physical testing, calibration of lab equipment and measurement tools, internal sensory evaluation are conducted as per schedule.

9. Report all non-conformances, discrepancies and/or deviations, and follow-up on the investigation of the non-conformity results.

10. Other projects as assigned.

As a Firmware Test Engineer in the Solid State Drive (SSD) group at Micron Technology, you will help ensure our SSD products have world-class performance and reliability. This outstanding opportunity allows you to collaborate with skilled experts to build flawless SSD firmware for enterprise and automotive markets. Your ambition and proven expertise will help us develop innovative solutions and advance technology.

Responsibilities

• Build comprehensive firmware verification plans for various firmware features.

• Develop white/ grey-box, known, and closed system testing methods to verify and validate firmware products.

• Analyze failures from weekly regressions and perform root-cause analysis, requiring deep SSD domain expertise.

• Manage test development, test deployment, test automation, and reporting activities.

• Communicate challenges, solutions, and mitigation plans to multi-functional teams and management with clear and effective communication of both technical and non-technical topics.

• Participate in code reviews and guide the team to ensure comprehensive coverage and accurate architectural build.

• Establish strong working relationships with firmware development engineers to improve code quality.

• Lead a team of technical people, as required.

Qualifications

• Bachelors/Masters in Electrical/Electronics Engineering, Computer Engineering, Computer Science or relevant majors

• Experience in SSD firmware architecture

• Comprehensive understanding and experience in SSD firmware testing and Python programming

• Understanding of storage industry protocols such as PCIe/ NVMe

• Familiarity with Agile development, GIT development flow and branch management.

• Experience with automated build, continuous integration, and test automation systems

• Highly organized, creative, motivated, and passionate about achieving results

• Ability to work on complex tasks independently with minimal supervision

• Demonstrated leadership abilities and the capability to mentor less experienced engineers

• Excellent problem-solving and analytical skills

• Strong interpersonal and communication skills, and a great teammate

Position Summary

This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Job Scope

1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others.

2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.

3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared.

4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.

5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system.

6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits.

7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.

8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions.

9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting root cause analysis.

10. Healthcare Quality Feedback: Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers.

11. Validation Programs: Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems.

12. Depot Support: Provide secondary / backup support to healthcare specialists for market depots.

Requirements :

1. Hold local pharmacist license

2. Have at least 5 -7 years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry in quality related role

3. Experience working in warehouse is desire

4. Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis

5. Have working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP,)/, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices,

6. Experience in local certifications in a warehouse and transportation business.

7. IATA CEIV certification knowledge would be at advantage but not necessary.

8. Experience in conducting external and internal audits for regions

9. Must hold at least Bachelor’s degree in Pharmacy from a reputable local institute in Singapore.

10. Occasionally travel is required to sites and region warehouses.

Competency

1. Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards

2. Problem-solving skills to support customer issue resolution

3. Planning & organization skills to ensure proper audit programs are managed effectively

4. Communication skills to facilitate engagements with customer and regulatory agencies

5. Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking

6. Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Working hours:

Mon to Fri 9am-6pm

Quality Operations Specialists must assist site management to oversee 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 are 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

• Minimum of 2 years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment.

• Prior experience in setting up of electronic batch records is a plus.

• 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

Duration: 6 months contract. (Option to renew/convert based on performance)