Senior QA Specialist

About the role

Pfizer is seeking a Senior QA Specialist to ensure the quality and regulatory compliance of its pharmaceutical products. The role supports manufacturing, packaging, and labeling processes while driving continuous improvement across quality systems.

Key responsibilities

• Review and approve master and batch records for intermediates and APIs, ensuring alignment with Pfizer quality standards and regulatory specifications.
• Approve cleaning instructions, GMP documents (SOPs, protocols, change controls) and deviations, managing investigations, root‑cause analyses, and corrective actions.
• Maintain quality tracking systems, monitor trends, and support preparation of the Annual Product Record.
• Participate in risk assessments such as FMEA for new product introductions and process changes.
• Serve as Designated Point of Contact and super‑user for quality platforms like Veeva Vault QMS and SAP.
• Support regulatory submissions, inspection readiness, and internal audits to ensure compliance with cGMPs.

Required profile

• Diploma with 8+ years, associate’s degree with 6+ years, or BA/BS with 4+ years of relevant QA experience.
• Solid understanding of current Good Manufacturing Practices (cGMP) and GxP regulations.
• Strong critical‑thinking abilities and proactive problem‑solving approach.
• Ability to work effectively within own team and cross‑functional teams.

Required skills

• Experience with Veeva Vault QMS.
• Proficiency in SAP.
• Use of AI tools, including Microsoft Copilot, for problem solving.
• Conducting Failure Modes and Effects Analysis (FMEA).
• Familiarity with quality administered systems.