Senior QC Chemist

Pfizer, S.A. de C.V; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Control Systems professional to manage QC lab equipment and processes. The role involves oversight of compliance, training, and collaboration with cross-functional teams to ensure quality standards are met. Ideal candidates will have a strong background in QC within the pharmaceutical industry and demonstrate leadership skills.

Benefits

Health and disability insurance

Preventative health programs

Parental leave policy

Childcare facilities

Qualifications

• Minimum 4 years QC experience in the pharmaceutical industry.
• Demonstrated leadership and customer service skills.
• Comprehensive knowledge of cGMPs and QC processes.

Responsibilities

• Manage the system life cycle of QC laboratory equipment.
• Ensure compliance with data integrity and SOPs.
• Lead investigations for deviations affecting QC systems.

Skills

Leadership

Communication

Problem Solving

Teamwork

Education

Degree or Diploma in Science (preferably Chemistry)

Tools

Minitab

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

The incumbent is a member of the Quality Control (QC) Systems team. Reporting to the QC Systems Manager, the incumbent will be responsible for systems related aspects supporting analytical testing in QC. These includes:

• Management of the system life cycle of QC laboratory equipment from purchasing, qualification, calibration & maintenance, periodic reviews, configuration and electronic data management to decommissioning.
• Set up and maintain QC processes (e.g. Stability program, Training plan for Analysts, Testing / Lab Release workflows and scheduling) and QC support of Continued Process Verification and/or Annual Product Reviews, including Stability and Batch testing data review / analysis.
• Lead QC processes / systems-related investigations and projects for improvement of QC processes.
• Mentor members within the Quality Control Laboratory team.
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

What You Will Achieve

Responsibilities:

• Perform all activities in the system life cycle of QC lab instruments / equipment (selection, qualification, user management, calibration, preventive maintenance, periodic reviews, configuration and electronic data management, decommissioning) in accordance to approved site procedures and applicable standards.
• Ensure all data management for QC instrument / equipment analysis data comply to site SOPs, Data Integrity (DI) and ALCOA requirements per PQS and that they are archived / retained in accordance to existing procedures.
• Provide oversight / supervision of GMP services provided by approved vendors for QC systems. Review and approve vendor documentation (e.g. qualification packages, calibration / test reports)
• Provide operational support (e.g. troubleshooting) for QC lab instruments / equipment to ensure batch release and lab testing activities is maintained inline with committed schedules.
• Develop, maintain and communicate QC laboratory testing/release capacity planning based on demand forecasts, testing / release lead times, resource availability (equipment, manpower) and budget requirements.
• Collaborate in cross functional teams (involving Supply Chain, Manufacturing, NPI etc) to provide inputs and adjustment to test activities to support production / product shipment / NPI schedules with appropriate escalation through Tier processes.
• Manage the stability testing program, ensuring all studies are promptly initiated and all test records are reviewed. Perform trending of stability data to confirm adverse trends, stability OOS or questionable results.
• Manage the training requirements for QC chemists, microbiologists and analysts including developing and maintaining training materials, coordinating trainings and conducting instructor-led trainings.
• Provide QC support of Continued Process Verification and Annual Product Review processes, including Stability and Batch testing data analysis and review.
• Author procedures governing QC systems and processes (equipment, data systems, stability, sample flow etc) and related technical documentation (e.g. protocols and reports) in accordance to Pfizer Quality Standards.
• Author training documentation and perform training (e.g. Structured On-The-Job Training or SOJTs) for fellow colleagues on SOPs pertaining to QC instruments / equipment and QC processes.
• Lead and conduct investigations for deviations affecting QC laboratory systems or processes (e.g. Equipment failure, Stability-related investigation, Analyst training program-related), identify root cause(s) and implement appropriate corrective action and preventive measures.
• Subject Matter Expert for area of work scope (e.g. Equipment qualification and maintenance program, Stability program, Analyst training program) and ensure adherence to site procedures and PQS.
• Lead projects for improvement of QC laboratory systems and processes including Data Integrity initiatives.
• Uphold Pfizer's code of conduct and values.
• Collaborate with cross-functional teams to drive flawless execution.
• 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.
• Mentor junior members (including interns) within the QC team

Here Is What You Need (Minimum Requirements)

Job Related Requirements:

• Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology/ Chemical Engineering
• For a Diploma: A minimum of 8 years QC experience in the pharmaceutical or related industry
• For a Degree: A minimum of 4 years QC experience in the pharmaceutical industry
• Demonstrated leadership and customer service skills.
• Demonstrate ability to act decisively and independently to resolve issues.
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team and provide mentorship to team members.
• Comprehensive knowledge of analytical laboratory equipment system life cycle and data integrity requirements.
• Comprehensive knowledge of cGMPs and QC processes (Stability program management, QC Analyst training programs, Continued Process Verification and Annual Product Review)
• Familiarity with statistical software (e.g. Minitab) and data analysis.
• Possess a can-do / pride to succeed attitude.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Bonus Points If You Have (Preferred Requirements)

• Strong understanding of computer system hardware, infrastructure, and networks
• Experience with Laboratory Information Management Systems (LIMS) and Empower system

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control#LI-PFE

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.

The incumbent is a member of the Quality Control (QC) Systems team. Reporting to the QC Systems Manager, the incumbent will be responsible for systems related aspects supporting analytical testing in QC. These includes:

• Management of the system life cycle of QC laboratory equipment from purchasing, qualification, calibration & maintenance, periodic reviews, configuration and electronic data management to decommissioning.
• Set up and maintain QC processes (e.g. Stability program, Training plan for Analysts, Testing / Lab Release workflows and scheduling) and QC support of Continued Process Verification and/or Annual Product Reviews, including Stability and Batch testing data review / analysis.
• Lead QC processes / systems-related investigations and projects for improvement of QC processes.
• Mentor members within the Quality Control Laboratory team.
• Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

What You Will Achieve

Responsibilities:

• Perform all activities in the system life cycle of QC lab instruments / equipment (selection, qualification, user management, calibration, preventive maintenance, periodic reviews, configuration and electronic data management, decommissioning) in accordance to approved site procedures and applicable standards.
• Ensure all data management for QC instrument / equipment analysis data comply to site SOPs, Data Integrity (DI) and ALCOA requirements per PQS and that they are archived / retained in accordance to existing procedures.
• Provide oversight / supervision of GMP services provided by approved vendors for QC systems. Review and approve vendor documentation (e.g. qualification packages, calibration / test reports)
• Provide operational support (e.g. troubleshooting) for QC lab instruments / equipment to ensure batch release and lab testing activities is maintained inline with committed schedules.
• Develop, maintain and communicate QC laboratory testing/release capacity planning based on demand forecasts, testing / release lead times, resource availability (equipment, manpower) and budget requirements.
• Collaborate in cross functional teams (involving Supply Chain, Manufacturing, NPI etc) to provide inputs and adjustment to test activities to support production / product shipment / NPI schedules with appropriate escalation through Tier processes.
• Manage the stability testing program, ensuring all studies are promptly initiated and all test records are reviewed. Perform trending of stability data to confirm adverse trends, stability OOS or questionable results.
• Manage the training requirements for QC chemists, microbiologists and analysts including developing and maintaining training materials, coordinating trainings and conducting instructor-led trainings.
• Provide QC support of Continued Process Verification and Annual Product Review processes, including Stability and Batch testing data analysis and review.
• Author procedures governing QC systems and processes (equipment, data systems, stability, sample flow etc) and related technical documentation (e.g. protocols and reports) in accordance to Pfizer Quality Standards.
• Author training documentation and perform training (e.g. Structured On-The-Job Training or SOJTs) for fellow colleagues on SOPs pertaining to QC instruments / equipment and QC processes.
• Lead and conduct investigations for deviations affecting QC laboratory systems or processes (e.g. Equipment failure, Stability-related investigation, Analyst training program-related), identify root cause(s) and implement appropriate corrective action and preventive measures.
• Subject Matter Expert for area of work scope (e.g. Equipment qualification and maintenance program, Stability program, Analyst training program) and ensure adherence to site procedures and PQS.
• Lead projects for improvement of QC laboratory systems and processes including Data Integrity initiatives.
• Uphold Pfizer's code of conduct and values.
• Collaborate with cross-functional teams to drive flawless execution.
• 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.
• Mentor junior members (including interns) within the QC team

Here Is What You Need (Minimum Requirements)

Job Related Requirements:

• Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology/ Chemical Engineering
• For a Diploma: A minimum of 8 years QC experience in the pharmaceutical or related industry
• For a Degree: A minimum of 4 years QC experience in the pharmaceutical industry
• Demonstrated leadership and customer service skills.
• Effective problem solving skills.
• Demonstrate ability to act decisively and independently to resolve issues.
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team and provide mentorship to team members.
• Comprehensive knowledge of analytical laboratory equipment system life cycle and data integrity requirements.
• Comprehensive knowledge of cGMPs and QC processes (Stability program management, QC Analyst training programs, Continued Process Verification and Annual Product Review)
• Familiarity with statistical software (e.g. Minitab) and data analysis.
• Possess a can-do / pride to succeed attitude.
• Embrace the use of digital technology to scale and speed up every form of interaction and action.

Bonus Points If You Have (Preferred Requirements)

• Strong understanding of computer system hardware, infrastructure, and networks
• Experience with Laboratory Information Management Systems (LIMS) and Empower system

Work Location Assignment:On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control#LI-PFE

Breakthroughs that change patients’ lives

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.

Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:

“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.

“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.

“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.

Our Values

To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.

Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.

Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.

Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.

Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

With an unwavering commitment to ensuring the availability and accessibility of these life-saving medications, we play a pivotal role in reaching patients, healthcare professionals, and markets across the globe.

Our network of state-of-the-art manufacturing facilities, strategically located distribution centers , and streamlined logistics systems enables us to deliver Pfizer's medicines with utmost efficiency and reliability, making a tangible difference in patients' lives worldwide.

Benefits at Pfizer

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.

Our Competitive Benefits Programs help our colleagues by:

• Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
• Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
• Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
• And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers , movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
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