Assistant Manager-QC

API manufacturing -QC

JOB DESCRIPTION:

1. Job role- Supervisor QC-Documentation & QMS and Reviewer

2. Follow Good Laboratory Practices as laid down in Quality Control Standard Operating procedures.

3. Review and follow up of schedule revision documents like Specifications, SOPs etc.

4. Implementation and monitoring of Quality control standard operating procedures. Preparation of Specifications for Raw materials, Intermediates. Finished products and stability studies

5. Investigation of Out of specification and laboratory incidents and documentation of such investigation including corrective and preventive action.

6. To initiate the change control and perform related activity.

7. To initiate the deviation form and perform related activity

8. Initiate the CAPA and perform related activity.

9. Monitoring Good laboratory practices, Good documentation practices as per standard operating procedures in Quality control department.

10. Monitoring and review regular calibration of all instruments of the Quality control laboratories, calibration whenever required. Approval of calibration reports in absence of QC Head.

11. Monitoring charging and disposal activity of Stability samples

12. Daily Audit trail review.

13. Monitoring and providing training New/Existing employee.

14. Preparation of Validation/Verification of analytical protocol and reports.

15. Management and qualification of working standard and reference standard and maintaining its records.

16. Follow up with purchase department for procurement of Chemicals, reagents, reference standards, columns and AMCs, of instruments.

17. Temperature and Humidity monitoring of Cooling cabinets and Stability chambers.

18. To monitor electronic Back-up of all QC instruments

19. Review qualification documents of QC instruments.

20. Preparation & monitoring schedule of Stability study, Calibration, Working standard, Preventive maintenance.

21. QC approval / release of Raw material and Recovered solvent in SAP and QC approval for Intermediate, Stability, Finished product, Microbiological analysis reports and Water analysis reports.

22. To perform and monitor joint analysis as and when required.

23. Investigation of Out of Calibration and documentation of such investigation including corrective and preventive action.

24. Preparation and Review of analytical protocol and report of Raw material, In-process, intermediate, Finished product and Stability.

25. To monitor routine preventive maintenance of quality control instrument and co-ordinate with Service engineer.

26. Preparation and Review of Certificate of Analysis (COA).

27. Preparation, Verification and control usage of validated MS Excel worksheet.

28. Monthly verification of safety alarm test for stability and Retention sample chambers.