Assistant Quality Control Manager

Role & responsibilities

1. To maintain Good Laboratories Practices.

2. Planning for finished and stability section on the priority.

3. Distribution of bulk, intermediate, finish product sample and stability sample for analysis.

4. Review of COA of finish product sample after analysis.

5. Review COA in LIMS.

6. Maintain the sampling collection room.

7. Checked by the data of COA in LIMS for finish goods and stability samples.

8. Review of analytical method validation data.

9. Review of stability protocol, report and raw data.

10. Review of technology transfer protocol, report and raw data.

11. Review of stability, in-process, raw material and finish product raw data after analysis.

12. Inform to QC Head\Designee and QA Head and Responsible for reporting of OOE,OOS,OOT ,incident, deviation , CAPA and change control as per procedure.

13. Review of SOP, specification, STP and GTP as per pharmacopeia or in-house.

14. Verify the record of analytical solutions used for HPLC analysis.

15. Review of Calibration record of all instruments as per the requirement.

16. Verify the destruction for finish goods and stability samples as per the procedure.

17. Review summery sheet of stability..

18. Maintained the destruction record of Stability and Finished products.

19. Review of stability samples and finish good samples.

20. Review of summary sheet after analysis.

21. Review of Trend data for the stability and finish samples.

22. Any other work assigned by Head QC as per requirement.