Quality Investigation Approver – Quality Assurance

About the role

Quality Investigation Approver – Quality Assurance at Pfizer. Independently review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological.

What you'll do

• Independently review, challenge, and approve deviation, non-conformance, OOS/OOT, complaint, environmental, microbiological
• Evaluate investigation strategies to ensure thorough fact-finding, evidence gathering, and identification of scientifically justified root causes
• Assess data integrity, documentation accuracy, and investigation completeness to ensure conclusions are supported by objective evidence
• Review the application of investigation tools including 5-Why Analysis, DMAIC, Fishbone Analysis, Fault Tree Analysis, Human Error Reduction tools
• Challenge unsupported assumptions, weak rationales, and bias to drive fact-based decision making

What you need

• 6–10 yrs of experience
• Root cause analysis
• GMP
• Technical writing
• ISO 9001
• Six Sigma
• Microbiology
• M.Sc or B.Pharm or M.Pharm

Good to have

• Lean
• Internal audit
• Chemistry