Key Responsibilities

• Perform microbiological testing of raw materials, in-process samples, finished products, and stability samples.
• Conduct environmental monitoring (EM) of cleanrooms, including viable and non-viable particle monitoring.
• Perform water system analysis such as WFI (Water for Injection), purified water, and clean steam testing.
• Carry out sterility testing, endotoxin testing (BET/LAL), and microbial limit tests as per approved procedures.
• Prepare and sterilize media, reagents, and culture media as per SOPs.
• Perform microbial identification, gram staining, and biochemical testing when required.
• Maintain laboratory instruments, incubators, autoclaves, biosafety cabinets, and ensure proper calibration status.
• Ensure accurate documentation of all microbiology testing activities in compliance with GMP and GDP.
• Review and verify test data, logbooks, and laboratory records.
• Investigate out-of-specification (OOS), out-of-trend (OOT), and deviations related to microbiology results.
• Ensure adherence to aseptic techniques and contamination control practices.
• Support validation activities including media fill simulations and method validation.
• Participate in internal audits, regulatory inspections, and compliance activities.
• Ensure proper disposal of biohazard waste as per safety and environmental guidelines.
• Maintain laboratory cleanliness and adherence to biosafety standards.