Manager- Microbiology (Sterile)

Roles and Responsibilities

1. Responsible for receipt of raw material, in process, miscellaneous and finish samples from the production blocks, making entries in the sample receipt records and planning of sample analysis accordingly.
2. To review the documents related to finish product release i.e. sterility test and bacterial endotoxin test and microbial limit test.
3. Responsible for reviewing the records of in process release of products i.e. bioburden analysis, antibiotic assay, biological indicators and packing materials.
4. To monitor the sample management system and planning of testing of raw material, in process samples packing material and finish product.
5. Responsible for ensuring the testing and releasing of raw material, packing material and finish products from microbiology laboratory as per defined procedure ans reviewing the results.
6. Responsible for preparation of validation/qualification protocol, execution of validation activities and review of report of microbiological methods in microbiology lab.
7. Managing deviation, change control, incidences with investigation and associated CAPA.
8. Investigation of OOS in the laboratory and associated CAPA.
9. Responsible for preparation of standard operating procedures, validation protocols and execution.
10. Responsible for the participation in media fill activity as planning.
11. Responsible for planning and qualification of microbiologist for various testing done in microbiology laboratory.
12. To impart trainings to the subordinates as per requirement in the company.
13. To participate in training programs organized by the company.
14. To ensure the cGMP ÂÂ norms are followed while performing analysis.
15. To maintain the inventories of the lab as per requirement.

Desired Candidate Profile

Perks and Benefits