Quality Assurance Compliance Lead

Job title: Quality Assurance Compliance Lead

About the Role This role provides quality assurance compliance oversight for the ZHOPL site and Pfizer Quality to ensure sustainable GMP compliance for Pfizer products manufactured at ZHOPL, aligned with the Pfizer quality agreement.

What You'll Do

• Provide overall QA compliance oversight for the ZHOPL site and Pfizer Quality to maintain GMP compliance for Pfizer products produced at ZHOPL.
• Review and authorize packed batch lots for distribution from ZHOPL to respective markets.
• Participate in SQRT for batch-related issue discussions as needed.
• Conduct regulatory impact assessments for changes to Pfizer products.
• Review and approve Change Controls at ZHOPL per Pfizer requirements.
• Perform Site Compliance Network Member (SCNM) activities at ZHOPL and create PAC and PCF in the PDM systems.
• Review and approve submission packages per REG-459.
• Review BoH queries, responses, and compendial/scientific data changes.
• Review and approve NPL assessments and dossier handover to ZHOPL.
• Coordinate complaint management for Pfizer products; review and approve investigation reports and upload to Pfizer's electronic complaint database.
• Support market actions and mock recalls by coordinating with site and Pfizer Market Action Leader.
• Assist with Supplier Quality Management for API, excipients, and critical processing aids per Pfizer Quality standards; perform ad-hoc supplier activities.
• Provide QMS support: assist in investigations (QARs), participate in SQRT investigations, support document reviews for new product launches and tech transfers, and review process validation documentation.
• Lead training activities and assist with GSOP reviews and implementations at the site and for Pfizer teams.
• Provide coverage for other urgent QA tasks, including investigations reviews, and manage Pfizer share points and digital systems for complaints, change controls, investigations, and supplier management.

What We're Looking For

• B. Pharm/ M. Pharm / M.Sc with minimum 6+ years of experience.
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, batch documents, customer complaints, investigations, training management, change controls, and document management.
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks.
• Excellent technical writing, communication, and presentation skills.
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software.
• Experience in preparing and participating in audits and inspections.

Nice to Have

• Background in handling complaints and utilizing electronic lab systems.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously.
• Experience in mentoring and training colleagues.
• Experience using common AI tools, including generative technologies such as ChatGPT or 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.

Compensation & Benefits

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