Senior QA Specialist (Investigations)

About the role

Pfizer is seeking a Senior QA Specialist to lead GMP investigations across manufacturing and laboratory sites. The role ensures product compliance with Pfizer Quality Standards and ICH guidelines while supporting a strong quality culture.

Key responsibilities

• Provide QA oversight of GMP investigations, issue management notifications, and implement batch controls such as holds and quarantines.
• Review and approve investigation reports, manufacturing records, CAPA documentation, and effectiveness checks.
• Ensure root‑cause analyses, corrective and preventive actions, and regulatory impact assessments are robust.
• Act as local process owner for investigation‑related quality systems and represent the site on global Process‑Centric Teams.
• Train site personnel on investigation roles and system access, serving as a QA approver.
• Perform Designated Point of Contact and super‑user duties for TrackWise and Vault QMS platforms.
• Prepare periodic review reports, analyse trends, and recommend continuous‑improvement actions.

Required profile

• Extensive experience in pharmaceutical quality assurance, GMP investigations, and regulatory compliance.
• Strong knowledge of Pfizer Quality Standards, ICH guidelines, and CAPA processes.
• Proven ability to mentor and train QA team members.
• Excellent analytical and problem‑solving skills with a focus on continuous improvement.

Required skills

• TrackWise
• Vault QMS

What we offer

• Opportunity to impact patient safety on a global scale.
• Collaborative environment with cross‑functional teams.
• Professional development and mentorship opportunities.