Assistant Manager Quality Control- Pharma Api Industry Job in Gennext India Private Limited

Roles and Responsibilities

1. SOP Review, revision and Harmonization.

2. New products analysis method review and arrange for necessary Corrections in test procedures.

3. Analytical method transfer activity and report protocol review.

4. Arranging AMC of Instrument and servicing.

5. Instrument spare procurement and maintenance.

6. Review of periodic calibration of Instruments.

7. Reference Standard procurement and management.

8. Monitoring the activity of working standard preparation and managements.

9. In- house training of Analysis and training of corporate training modules.

10. Review Analyst Qualification/ certification.

11. Departmental correspondence, Internal and external Audit compliance action.

12. Co-ordination with maintenance Dept for QC Dept utilities and its Maintenance.

13. Review Qualification of Laboratory Instruments Equipment.

14. Change control, OOS, OOT, Incident and deviation & CAPA Handling.

15. Monitoring of stability sample analysis, Microbiology Lab record review.

16. To check Pharmaceutical addendum & supplement to make necessary amendment in the specification, whenever change in the Pharmacopoeia is observed.

17. Co-ordination for SCM related activity with IT and QA

18. Storage of Laboratory data & records.

19. Instrument Data back up, and software users rights.

20. Arranging for outside testing and calibrations and its report Review.

21. Approval and Rejection of Raw Material, Packing Material & Intermediates products.

22. Review of analytical results/data of in-process. Intermediate, water analysis finished API and issue COA for each batch of API.

23. Trouble shooting of the QC Instruments.