Sr. Executive QC (Reviewer)

- 1. Review of Raw Material (RM) Documentation like Raw Material test reports, Certificates of Analysis (CoA), specifications and analytical results
- 2. Review of In-Process (IP) & Bulk Product Documentation like In-Process test reports and analytical records
- 3. Finished Product (FP) Documentation Review like Finished Product analytical reports, test results and Certificates of Analysis
- 4. GLP Documentation & Laboratory Compliance
- 5. Specification Preparation & Revision
- 6. Method of Analysis (MoA) Preparation & Review
- 7. Pharmacopoeial & Regulatory Update
- 8. Calibration Documentation Review
- 9. Instrument & Equipment Documentation like IQ/OQ/PQ, calibration and preventive maintenance records
- 10. OOS/OOT & Laboratory Investigation Support
- 11. Document Control
- 12. Audit & Inspection Readiness
- 13. Training & Compliance

Sr. Executive QC (AMV)

Analytical Method Verification, Finished Product & Stability Testing

1. Analytical Method Verification

- Plan, coordinate and execute analytical method verification for pharmacopoeial and other validated methods prior to routine use.
- Prepare and review Method Verification Protocols and Reports in accordance with approved procedures and applicable regulatory requirements.
- Assess method suitability for the specific product, formulation, equipment and laboratory conditions.




- Verify applicable analytical.

2. Finished Product Analytical Testing

- Perform analytical testing of Finished Products in accordance with approved specifications and Methods of Analysis.
- Ensure testing is performed using current approved analytical procedures and qualified/calibrated instruments.
- Review sample identification, batch details, sampling information and test requirements before analysis.

3. Stability Sample Testing

4. Analytical Data Review & Data Integrity

5. OOS / OOT / Atypical Result Investigation

6. Laboratory Instrument & Equipment Compliance

- Ensure instruments used for finished product and stability testing are qualified and within valid calibration/maintenance status.

7. Method & Specification Compliance

- Ensure all testing is performed against the current approved specification and Method of Analysis.

8. Stability Trend Analysis

- Periodically review and trend stability data for critical quality attributes.

9. Regulatory & Pharmacopoeial Compliance

- Ensure analytical testing is aligned with applicable requirements of IP, USP, BP, Ph. Eur. and other applicable pharmacopoeias, as relevant to the product and market.

10. Audit & Inspection Readiness

11. Training & Technical Development

📌 Senior Qc Executive (Dharwad)
🏢 Wallace Group
📍 Dharwad