Assistant Manager | Microbiology | Acme Generics | Nalagarh | 7.50-10.00 L

Job Description

• 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