We are looking for Senior QA Consultants (7+ 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
- 7+ years in Pharmaceutical Quality Assurance.
- Proven hands-on experience authoring and completing PQR/APQR reports (not just reviewing or approving them).
- Solid understanding of US FDA, EU GMP, ICH, WHO, and PIC/S GMP requirements.
- Experience with data analysis, quality metrics, and annual product review documentation.