Manager- Quality Control (Micro)

GUFIC BIOSCIENCES LIMITED; Indore District; On-site; INR 2,500,000 - 4,000,000; Full time

Benefits offered by this job

Competitive compensation

Job summary

GUFIC BIOSCIENCES LIMITED in Pithampur, MP, is seeking an experienced Manager Microbiology to lead the QC Microbiology function for sterile/injectable manufacturing. You will oversee environmental monitoring, sterility testing, and microbial testing of raw materials, water, and products, while ensuring regulatory and data integrity compliance.

The role requires 14-17 years in pharma microbiology, strong leadership skills, and proven experience with deviations, CAPA and audits.

Qualifications

• 14-17 years of relevant experience in microbiology in pharma manufacturing (preferably sterile/injectable).
• Strong hands-on experience in Environmental Monitoring, Sterility Testing, BET, microbial testing, media preparation and aseptic microbiology.
• Experience handling deviations, OOS/OOT, CAPA, change controls and regulatory/customer audits.
• Good GMP/GLP, pharmacopoeial requirements and data integrity knowledge.

Responsibilities

• Lead and manage the Microbiology function for sterile/injectable manufacturing operations.
• Ensure GMP/cGMP, Schedule M compliance and regulatory guidelines.
• Supervise microbiology testing of raw materials, water, environmental monitoring, finished products and in-process samples.
• Oversee Environmental Monitoring, personnel monitoring, aseptic area monitoring and microbial limit testing.
• Review and approve microbiology test results, worksheets and laboratory records.
• Investigate OOS/OOT, deviations, CAPA and change controls related to microbiology.
• Ensure data integrity and good documentation practices.
• Manage media preparation, growth promotion testing, culture handling and reference cultures.
• Oversee media fill, sterility testing and endotoxin testing as applicable.
• Ensure qualification, calibration and maintenance of microbiology lab equipment.
• Lead root-cause investigations and corrective actions for contamination.
• Prepare for regulatory inspections and customer audits; close observations timely.
• Train microbiology personnel on GMP, aseptic practices and data integrity.

Job description

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.

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