Microbiology Manager

Job Description 1. Responsible for management of Microbiology lab. 2. Responsible for allocation of work in Microbiology lab. 3 To monitor sample management system and planning of testing and release of raw material, in-process samples, validation samples, packing material and finished product from microbiology laboratory as per defined procedure. 4. Responsible for ensuring the testing and release of raw material, packing material and finished product as per agreed timelines. 5. Responsible for reviewing and approving the documents related to microbiological testing. 6. Responsible for managing Environmental monitoring, Utility monitoring (water/Compressed gases) programmes. 7. Managing deviations, change control, incidents with investigations and associated CAPA. 8. Responsible for leading, investigating and closure of Microbiology Out of Specification Results and finalization of associated CAPA. 9. Responsible for reviewing of Standard Operating Procedures, imparting training on new/changed procedures and assuring implementation of the same in Microbiology lab. 10.Responsible for preparation of qualification/validation protocols, ensuring validations/qualifications are executed appropriately as per the procedures and reviewing/approving the validation/qualification reports. 11. Responsible for planning and management of Microbiology related activities during Aseptic Process Simulation. 12. Responsible for participation in activities related to Sterility Assurance of product/process. 13.To impart training to subordinates on aseptic techniques/behaviours and sterility assurance elements. 14.To lead regulatory/customer audits wrt Microbiology operations and ensure that any actions generated for Microbiology are completed as per agreed timelines. 15.Responsible for enhancing overall compliance in Microbiology lab as per current regulatory expectations. 16.To perform any other work assigned by the head of the department based on need of organization. 17.To follow good documentation practices. 18.To adhere the cGMP standards. 19.To adhere to the organization rules and regulation.