Pfizer

Senior QA Specialist

Posted Yesterday

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Singapore, SGP

In-Office

Senior level

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical

We’re in relentless pursuit of breakthroughs that change patients’ lives.

The Role

Reviews and approves GMP records, quality documents, deviations, investigations, CAPAs, change controls, and API disposition activities. Maintains quality systems, metrics, inspection readiness, validated processes, and regulatory compliance. Supports audits, submissions, risk assessments, and continuous improvement while mentoring junior QA staff and participating in EHS initiatives.

Summary Generated by Built In

Use Your Power for Purpose
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:

Review and approve master batch records and executed batch records for the manufacture, packaging, and labelling of intermediates and active pharmaceutical ingredients (APIs), ensuring compliance with Pfizer quality standards and registered regulatory specifications.
Perform disposition of intermediates and active pharmaceutical ingredients (APIs).
Review and approve cleaning instructions and records to ensure compliance with Pfizer global and local documents.
Review and approve GMP documents, including SOPs, protocols, reports, and change controls, to ensure compliance with Pfizer global and local documents.
Ensure compliance with quality procedures, regulatory requirements, and current Good Manufacturing Practices (cGMPs).
Review and approve deviations in accordance with site procedures, including investigation reports, root cause analyses, corrective and preventive actions, and impact assessments conducted with subject matter experts for quality, validation, stability, and regulatory considerations. Escalate issues in accordance with Pfizer global and local documents.
Serve as the Designated Point of Contact (DPOC) and super user for assigned site platforms supporting quality systems, such as Veeva Vault QMS and SAP, when nominated.
Maintain quality tracking systems and metrics to proactively identify trends and atypical observations.
Support preparation of the Annual Product Record, evaluate trends and atypical observations, and recommend improvement actions.
Participate in process risk assessments, such as Failure Modes and Effects Analysis (FMEA), for new product introductions and process changes.
Assess site procedures against Pfizer global and local documents, recommend actions to close identified gaps and mitigate risks, and conduct internal audits to confirm the effectiveness of internal controls.
Maintain inspection readiness and support regulatory and customer inspections. Participate actively in GMP walkthroughs to ensure site operations and facilities remain inspection ready.
Support the maintenance of GMP systems and processes in a validated state.
Support regulatory submissions and respond promptly to regulatory queries.
Uphold Pfizer's Code of Conduct and values, demonstrate actionable attributes.
Contribute actively within the assigned Value Stream Team (VST) by reporting performance against metrics, identifying and resolving issues, escalating as appropriate, and developing and implementing effective solutions.
Lead improvements to Quality Assurance systems, as required.
Mentor junior members of the Quality Assurance team, including interns.
Participate actively in safety initiatives and conduct Environment, Health and Safety (EHS) investigations, as required.

Here Is What You Need (Minimum Requirements)

Diploma with 8+ years of relevant experience or associate's degree with 6+ years of relevant experience or BA/BS with 4+ years of relevant experiences
Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
Strong critical thinking skills
Ability to work effectively within own team and interdepartmental teams
Proactive approach to problem-solving

Bonus Points If You Have (Preferred Requirements)

Experience in quality administered systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review the work of other colleagues
Experience using common AI tools, including generative technologies such as Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

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.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control

Skills Required

Diploma with 8 or more years of relevant experience, associate degree with 6 or more years, or bachelor's degree with 4 or more years
Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
Strong critical thinking skills
Ability to work effectively within the team and with interdepartmental teams
Proactive approach to problem-solving
Experience with quality administration systems
Strong organizational skills and attention to detail
Experience with regulatory compliance and documentation
Ability to mentor and review colleagues' work
Experience using common AI tools, including Microsoft Copilot and generative AI technologies, with understanding of responsible AI practices

What the Team is Saying

Pfizer Compensation & Benefits Highlights

Healthcare Strength — Health coverage is described as comprehensive across medical, dental, vision, and mental‑health support, with strong plan options and provider networks. Feedback suggests these programs are a clear standout within the total rewards package.
Retirement Support — Retirement programs feature a 401(k) with company matching plus an additional company retirement contribution. Feedback suggests these elements are consistently highlighted as valuable components of overall compensation.
Leave & Time Off Breadth — Paid vacation, holidays, and sick time are often characterized as generous, with some locations offering the ability to purchase additional vacation days. Feedback suggests this breadth contributes meaningfully to work‑life balance.

Learn more about Pfizer's Compensation & Benefits →

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The Company

HQ: New York, NY

121,990 Employees

Year Founded: 1848

What We Do

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.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.