Microbiology-AGM

Key Responsibilities

• Lead the Microbiology laboratory and ensure effective execution of microbiological testing activities.
• Oversee testing of raw materials, finished products, water systems, environmental monitoring samples, and in-process samples.
• Manage sterility testing, bacterial endotoxin testing (BET), microbial limits testing, bioburden, and other microbiological analyses.
• Ensure effective Environmental Monitoring (EM) of classified areas, including viable and non-viable monitoring programs.
• Drive Contamination Control Strategy (CCS) and microbiological control programs for sterile manufacturing operations.
• Review and approve microbiology-related SOPs, specifications, protocols, reports, investigations, and validation documents.
• Lead investigations related to OOS, OOT, environmental monitoring excursions, microbial contamination, sterility failures, and laboratory deviations.
• Ensure compliance with USFDA, EU GMP, WHO GMP, Schedule M, and other applicable regulatory requirements.
• Provide microbiological support for media fills/aseptic process simulations, cleaning validation, process validation, and disinfectant efficacy studies.
• Oversee growth promotion testing, culture maintenance, microbial identification, media preparation, and laboratory controls.
• Ensure qualification, calibration, maintenance, and effective utilization of microbiology laboratory equipment.
• Establish and monitor microbiological trends, including environmental monitoring and water-system data.
• Participate in regulatory inspections, customer audits, internal audits, and mock inspections, and ensure timely closure of observations.
• Ensure ALCOA+ / Data Integrity principles are followed in all microbiological laboratory activities.
• Develop team capability through training, competency assessment, and technical development.
• Coordinate with Production, QA, Engineering, Validation, and other QC functions for microbiological risk management.
• Drive continuous improvement initiatives in microbiology laboratory operations and contamination control.

Key Technical Areas

• Sterility Testing
• Environmental Monitoring
• Bioburden & Microbial Limit Testing
• Bacterial Endotoxin Testing
• Water & Utility Microbiology
• Media Fill / Aseptic Process Simulation
• Growth Promotion Test
• Microbial Identification
• Disinfectant Efficacy
• Contamination Control Strategy
• Cleaning & Process Validation Support
• OOS / OOT / Deviation Investigation
• Microbiological Trending
• Data Integrity & GMP Compliance

Qualification

M.Sc. / M.Pharm / B.Pharm / equivalent qualification in Microbiology or relevant Life Sciences discipline.

Experience

• 1520+ years of relevant experience in pharmaceutical microbiology.
• Strong experience in sterile injectable manufacturing environments.
• Exposure to USFDA / EU GMP / WHO regulatory requirements and regulatory inspections.
• Experience in managing microbiology teams and laboratory operations at a managerial level.

Competencies

• Strong knowledge of sterile manufacturing and microbiological control
• Regulatory and GMP compliance
• Investigation and root-cause analysis
• Contamination control and risk management
• Team leadership and people management
• Audit and inspection management
• Decision-making and problem-solving
• Strong documentation and communication skills

Preferred Experience

Candidates with experience in USFDA-inspected sterile injectable facilities, regulatory inspection handling, and implementation of Contamination Control Strategy (CCS) will be preferred.