Senior Microbiologist-QC FDA

Role & responsibilities

1. Microbiological analysis of water & finish products.

2. Maintain Micro lab with respect to temp, humidity, pressure differential etc.

3. Environmental monitoring.

4. Maintaining microbial culture.

5. Media Preparation & steri I ization.

6. Maintaining a1l labels (Autoclave, Media Preparation, Calibration, Media receipt &

consumption, Fumigation etc)

7. Validation of instruments with collaboration of outside party

8. Strict Adherence to GLP.

9. Sampling of Purified water and MIDC water as per SOP.

10. To carry out microbiological and chemical analysis of water as per Standard Test Procedure.

11. To maintain the records of media preparation, sterilization, Growth promotion test, culture maintenance.

12. To carry out Microbiological analysis for finish product for microbial contamination test.

13. To carry out Microbiological environment monitoring of clean room area and manufacturing area.

14. To maintain the record for instruments/equipments in microbiology laboratory.

15. To review analytical data for microbial analysis.

16. To maintain the laboratory for good housekeeping.

17. To perform various validations water system, cleaning etc.

18. To prepare & review of SOP, STP, Specifications, Validation protocol & report.

19.  To perform calibration of instruments/equipments.

20.  Batch release for microbial limit test.