Qc Analyst

Key Responsibilities:

1. Perform sampling of raw materials and finished products in accordance with approved sampling procedures.

2. Conduct analysis of raw materials, in-process samples, finished products, and

stability samples as per approved specifications and test methods,

3. Prepare and issue Certificates of Analysis (CoA) and ensure timely release of test

results.

4. Operate analytical instruments such as GC, Karl Fischer, FTIR and other laboratory

instruments.

5. Perform routine calibration, verification, performance checks, and maintenance

activities for laboratory instruments and equipment

6. Maintain and manage retention samples in accordance with approved procedures

and retention requirements.

7. Ensure accurate recording of analytical results in laboratory worksheets, logbooks,

electronic systems, and test reports in compliance with GDP and ALCOA+

principles.

8. Maintain laboratory documentation including SOPs, specifications, analytical

methods, logbooks, and inventory records.

9. To provide analytical support and data reporting to assist other functions with

troubleshooting and problem solving for the site.

10. Monitor laboratory inventory, reagents, reference standards, columns, chemicals,

and consumables and initiate replenishment requests as required.

11. Support method validation, method verification, method transfer, and laboratory

qualification activities.

12. Ensure compliance with laboratory safety practices, use of PPE, proper chemical

handling, waste disposal procedures, and housekeeping standards.

13. Ensure compliance with GMP, IMS, EFfCI GMP, EXCiPACT, Halal, Kosher, and

other applicable regulatory and customer requirements.

14. Participate in investigation of Out of Specification (OOS), laboratory incidents,

deviations, and customer complaints.

15. Support implementation and monitoring of CAPAs, Change Controls, and Quality

Risk Assessments related to laboratory activities. Contribute to continuous

improvement initiatives and troubleshooting activities.

16. Participate in internal audits, customer audits, certification audits, and regulatory

inspections, and assist in closure of audit observations.

17. To implement and maintain appropriate training regimes for new and existing QC

staff to meet departmental objectives.

18. Coordinate with cross-functional teams on quality issues and support corrective

actions.

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