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
- Solid 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.

📌 Microbiology-AGM (Hyderabad)
🏢 Aspiro Pharma
📍 Hyderabad