Sr. Executive QC (Reviewer)

- 1. Review of Raw Material (RM) Documentation like Raw Material test reports, Certificates of Analysis (CoA), specifications and analytical results
- 1. Review of In-Process (IP) & Bulk Product Documentation like In-Process test reports and analytical records

- 1. Finished Product (FP) Documentation Review like Finished Product analytical reports, test results and Certificates of Analysis

- 1. GLP Documentation & Laboratory Compliance

- 1. Specification Preparation & Revision

- 1. Method of Analysis (MoA) Preparation & Review

- 1. Pharmacopoeial & Regulatory Update

- 1. Calibration Documentation Review

- 1. Instrument & Equipment Documentation like IQ/OQ/PQ, calibration and preventive maintenance records

- 1. OOS/OOT & Laboratory Investigation Support

- 1. Document Control

- 1. Audit & Inspection Readiness

- 1. 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