Head Microbiology

JOB DESCRIPTION Key responsibilities: - Ensure compliance to cGMP and safety standards in the Microbiology Lab. - Conduct work planning and allotment to analysts for sample testing. - Ensure Calibration/Preventive Maintenance/Qualification of laboratory equipment and instruments - Ensure environmental monitoring of Microbiology Laboratory. - Ensure sample management & sanitization activity in Microbiology lab sample - Ensure microbiological analysis of sterile and non-sterile raw materials, in-process samples and finished products, PM and Stability. - Evaluate and ensure analytical data and calculation of results. - Assist with reporting and verification of test results/reports. - Ensure timely preparation of Validation protocols/reports other quality documents. - Initiate /execute QMS activity pertaining to micro lab activity. - Ensure review & approve QMS activity pertaining to micro lab activity. - Provide microbiological support in plant validation & qualification activities. - Provide troubleshooting support to analysts. - Ensure for in process activities related to Sterility Assurance on shop floor. - Ensure timely training and qualification of all Microbiology personnel as per schedule/requirement. - Coordinate for various activities with laboratories & manufacturing/customer’s and ensures to provide timely & necessary support to fulfil organizational requirements. - Support IPQA, QA, Production, PDL, Regulatory, Stability Lab, API and Validation for microbiological requirements. - Co-ordination for internal/external audits , and ensure compliance during internal as well as regulatory audits. - Ensure conformance to internal Quality Systems requirements and relevant markets’ regulatory guidelines on cGMP with respect to Microbiological requirement. - Ensure for technical up gradation of activities whenever required. - Actively participate in all Validation, Qualification and process enhancement activities and to ensure conformance to internal Quality Systems requirements and relevant markets’ regulatory guidelines on cGMP with respect to Microbiological requirement.

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