Manager- Quality Control (Micro)

Roles and Responsibilities

Position: Manager Microbiology
Department: Quality Control Microbiology
Location: Pithampur, M.P. ( Near Indore)

Key Responsibilities

• Lead and manage the Microbiology function for sterile/injectable manufacturing operations.
• Ensure compliance with GMP, cGMP, Schedule M, pharmacopoeial requirements and applicable regulatory guidelines.
• Supervise microbiological testing of raw materials, water, environmental monitoring, finished products, in-process samples and other microbiological samples.
• Ensure effective execution of Environmental Monitoring (EM), personnel monitoring, aseptic area monitoring and microbial limit testing.
• Review and approve microbiology test results, worksheets, analytical data, trends and laboratory records.
• Ensure proper handling and investigation of OOS/OOT, deviations, incidents, CAPA and change controls related to microbiology.
• Ensure compliance with data integrity, ALCOA+ principles and good documentation practices.
• Monitor and manage media preparation, growth promotion testing, culture handling, identification and maintenance of reference cultures.
• Oversee media fill support, sterility testing and bacterial endotoxin testing, as applicable.
• Ensure qualification, calibration and maintenance of microbiology laboratory equipment.
• Review microbiological trends and identify potential contamination risks in manufacturing areas.
• Lead root-cause investigations related to microbial contamination and recommend appropriate corrective/preventive actions.
• Ensure readiness for regulatory inspections and customer audits and support timely closure of observations.
• Train, guide and develop microbiology personnel on GMP, aseptic practices, microbiological techniques and data integrity.
• Ensure adequate manpower, laboratory resources, consumables and timely completion of testing activities.
• Coordinate with Production, QA, Engineering and other QC functions for investigation and resolution of microbiological issues.

Qualification & Experience

• M.Sc./M.Tech. in Microbiology / Biotechnology / Life Sciences or equivalent qualification.
• 14 - 17 years of relevant experience in the Microbiology function of a pharmaceutical manufacturing environment, preferably sterile/injectable formulations.
• Strong hands-on experience in Environmental Monitoring, Sterility Testing, BET, microbial testing, media preparation and aseptic microbiology practices.
• Experience in handling deviations, OOS/OOT, CAPA, change controls and regulatory/customer audits.
• Good knowledge of GMP, GLP, pharmacopoeial requirements and data integrity principles.

Key Competencies

• Strong knowledge of sterile pharmaceutical microbiology.
• Leadership and team-management skills.
• Strong analytical and investigation skills.
• Good documentation and communication skills.
• Sound understanding of contamination control and aseptic practices.
• Ability to manage laboratory operations and regulatory compliance effectively.

Email Id : [email protected]