Senior QA Consultant – Product Quality Review (PQR/APQR)

Senior QA Consultant – Product Quality Review (PQR/APQR)

Requirement

We are looking for Senior QA Consultants (10+ years of experience) to support with the preparation of Product Quality Reviews (PQR/APQR).

Key Responsibilities

• Independently prepare Product Quality Reviews (PQR/APQR) for commercial pharmaceutical products.
• Collect and analyze data from Manufacturing, Quality Control, Stability, Deviations, CAPA, Change Controls, Complaints, Recalls, and Validation.
• Perform trend analysis and identify recurring quality issues and process improvement opportunities.
• Compile PQR reports in compliance with cGMP and global regulatory expectations.
• Coordinate with cross-functional stakeholders to obtain required data and resolve gaps.
• Ensure timely completion of PQRs within project timelines.

Mandatory Experience

• 10+ years in Pharmaceutical Quality Assurance.
• Proven hands-on experience authoring and completing PQR/APQR reports (not just reviewing or approving them).
• Strong understanding of US FDA, EU GMP, ICH, WHO, and PIC/S GMP requirements.
• Experience with data analysis, quality metrics, and annual product review documentation.