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

Requirement

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).
- Robust understanding of
US FDA, EU GMP, ICH, WHO, and PIC/S
GMP requirements.
- Experience with data analysis, quality metrics, and annual product review documentation.

📌 Senior QA Consultant – Product Quality Review (India)
🏢 vueverse.
📍 India