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.

- Robust 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]

📌 Manager- Quality Control (Micro) (Indore)
🏢 Gufic Biosciences
📍 Indore