Micro Assistant Manager/Deputy Manager- API

Role & responsibilities

1. Responsible to review documentation related to Microbiology laboratory.

2. To ensure proper sampling and testing of DI water, raw water and drinking water as per the method of analysis.

3. To ensure environment monitoring program as per the schedule.

4. Responsible for review all the relevant records of microbiology testing.

5. Responsible for review of sanitization of microbiology as per the defined schedule.

6. To ensure qualification and calibration of instrument used for microbiology testing.

7. To ensure the proper temperature, RH and differential pressure monitoring in microbiologist lab.

8. To send sample for microbiology analysis to outside contract labs.

9. To prepare STPs, SOCP, SCPs of QC.

10. Responsible for checking all microbiology log book/records/conduct lab investigation.

11. Responsible for reporting /reviewing of OOS/OOT and to conduct lab investigation.

12. Managing deviation, change control, incidences with investigation and associated CAPA.

13. To review validation/revalidation, qualification studies involved in microbiology.

14. To ensure that STP is followed in analysis.

15. Responsible for preparation of standard operating procedures, validation protocols and execution.

16. To review GMP related protocols and reports.