Senior QA Specialist

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.