The QA Reviewer is responsible for reviewing and verifying quality-related documents, records, and reports to ensure compliance with cGMP, regulatory requirements, and company SOPs. The role involves documentation review, data integrity checks, and ensuring that all activities are performed in accordance with established quality standards.

Key Responsibilities

1. Review and verify batch manufacturing records (BMR) and batch packaging records (BPR).

2. Review analytical documents, QC reports, raw data, and laboratory records.

3. Verify SOPs, specifications, protocols, validation reports, and other quality documents.

4. Ensure compliance with cGMP, GLP, ICH guidelines, and applicable regulatory requirements.

5. Review documentation for accuracy, completeness, traceability, and data integrity.

6.



Identify documentation errors, discrepancies, and non-compliances and coordinate for necessary corrections.

7. Review deviations, Out of Specification (OOS), Out of Trend (OOT), and CAPA documentation.

8. Ensure proper documentation practices in accordance with ALCOA+ principles.

9. Coordinate with QA, QC, Production, and other departments for documentation-related activities.

10. Support internal audits, customer audits, and regulatory inspections.

11. Ensure timely completion and closure of assigned documentation reviews.

12. Maintain proper document control and archival practices.

📌 QA Reviewer (Hyderabad)
🏢 Ritsa Pharma
📍 Hyderabad