Microbiologist

Job Description

We are looking for a Microbiologist to join the Quality Control team in our pharmaceutical manufacturing facility manufacturing sterile and non-sterile products. The role will involve environmental monitoring, water system testing, and microbiological release testing across dedicated manufacturing blocks, and requires strong familiarity with current regulatory expectations under Revised Schedule M, WHO-GMP, and other applicable frameworks.

Key Responsibilities

• Be responsible for the Environmental Monitoring Program (viable and non-viable particulate monitoring) across classified areas, including block-specific protocols for General and Cephalosporin manufacturing areas.
• Perform microbiological testing of raw materials, in-process samples, and finished products, including Bioburden, Microbial Limit Test (MLT), and Bacterial Endotoxin Test (BET).
• Conduct sterility testing and support Aseptic Process Simulation / Media Fill Validation studies.
• Carry out routine testing and trending of Purified Water and Water-for-Injection (WFI) systems.
• Perform Growth Promotion Testing, media/reagent qualification, and maintain culture collections.
• Support qualification and calibration activities for microbiology lab equipment (autoclaves, incubators, LAF/BSCs, particle counters).
• Maintain GMP-compliant documentation SOPs, protocols, logbooks, and reports in line with Schedule M (2023) and WHO-GMP requirements.
• Investigate microbiological out-of-specification (OOS) and out-of-trend (OOT) results, and support deviation/CAPA closure.
• Ensure segregation and cross-contamination controls are followed per facility design, especially across the Cephalosporin-dedicated zones.
• Support internal audits and regulatory inspections (WHO-GMP, USFDA, State FDA, etc.) with audit-ready documentation.

Desired Candidate Profile

• Freshers are welcome to apply.
• Hands-on experience in a pharmaceutical microbiology lab, preferably in a sterile/injectable manufacturing environment.
• Working knowledge of Beta-Lactam or Cephalosporin handling protocols is an added advantage
• Sound understanding of current Indian regulatory requirements (Revised Schedule M) alongside WHO-GMP and/or USFDA expectations.
• Detail-oriented, comfortable with rigorous documentation, and able to work within a cleanroom/controlled environment
• Good communication skills for cross-functional coordination with QA, Production, and Engineering