Date PostedSeptember 17, 2022
Location (State / UT)
Experience8 Years, 12 Years
Desired QualificationMaster’s Degree
- 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.
- To review the documents related to finishing product release i.e. sterility test and bacterial endotoxin test and microbial limit test.
- Responsible for reviewing the records of the in-process release of products i.e. bioburden analysis, antibiotic assay, biological indicators, and packing materials.
- To monitor the sample management system and planning of testing of raw material, in-process samples packing material, and finished product.
- Responsible for ensuring the testing and releasing of raw material, packing material, and finished products from microbiology laboratory as per defined procedure and reviewing the results.
- Responsible for preparation of validation/qualification protocol, execution of validation activities, and review of the report of microbiological methods in the microbiology lab.
- Managing deviation, change control, incidences with the investigation, and associated CAPA.
- Investigation of OOS in the laboratory and associated CAPA.
- Responsible for preparation of standard operating procedures, validation protocols, and execution.
- Responsible for the participation in media fill activity as planning.
- Responsible for planning and qualification of microbiologists for various testing done in the microbiology laboratory.
- To impart training to the subordinates as per requirement in the company.
- To participate in training programs organized by the company.
- To ensure the cGMP norms are followed while performing analysis.
- To maintain the inventories of the lab as per requirement.
Qualification: MS/M.Sc(Science) in Biotechnology, Microbiology