Assistant Quality Control Manager

Immacule Life Sciences; Solan; On-site; INR 300,000 - 420,000; Full time

Job summary

Immacule Life Sciences is seeking to reinforce its quality control team with a dedicated professional to ensure adherence to GLP and robust review of stability and finished product analytics. You will manage COA reviews, LIMS data, method validation, and CAPA reporting, while maintaining destruction records and overseeing sample handling across stability and finished goods.

The role requires meticulous documentation, adherence to SOPs, and proactive communication with QC and QA heads.

Responsibilities

• Maintain Good Laboratories Practices.
• Plan for finished and stability section on the priority.
• Distribute bulk, intermediate, finish product sample and stability sample for analysis.
• Review COA of finish product sample after analysis.
• Review COA in LIMS.
• Maintain the sampling collection room.
• Verify data of COA in LIMS for finish goods and stability samples.
• Review analytical method validation data.
• Review stability protocol, report and raw data.
• Review technology transfer protocol, report and raw data.
• Review stability, in-process, raw material and finish product raw data after analysis.
• Inform QC Head/Designee and QA Head and responsible for reporting OOE, OOS, OOT, incidents, deviations, CAPA and change control as per procedure.
• Review SOP, specification, STP and GTP as per pharmacopeia or in-house.
• Verify the record of analytical solutions used for HPLC analysis.
• Review calibration records of all instruments as per requirement.
• Verify the destruction for finish goods and stability samples as per procedure.
• Review summary sheet of stability.
• Maintain the destruction record of Stability and Finished products.
• Review stability samples and finish good samples.
• Review summary sheet after analysis.
• Review trend data for stability and finish samples.
• Any other work assigned by Head QC as per requirement.

Job description

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.