Senior Qc Executive

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