Microbiology Expert

Job Title: Microbiology Specialist

We are seeking a skilled Microbiology Specialist to join our team.

Key Responsibilities:

• Perform environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
• Sampling and testing of purified water and raw water.
• To perform Microbial Limit tests, BET, Sterility testing etc of water, API's and KSM's
• Support for cleaning validation by performing swab/rinse microbiological analysis.
• Conduct microbiological validation studies (e.g., filter integrity testing, media fills for aseptic processes).
• Participate in qualification of controlled areas, equipment, and utilities (HVAC, water systems, compressed air).
• To Prepare and review Standard Operating Procedures (SOPs), protocols, and reports.
• Maintain accurate microbiological records as per GMP and data integrity requirements (ALCOA+ principles).
• Support regulatory inspections and customer audits and respond to microbiology-related queries.
• Participate in out-of-specification (OOS) or out-of-trend (OOT) investigations related to microbial results.
• Perform root cause analysis and propose corrective and preventive actions (CAPA).
• Conduct microbiological risk assessments of processes and systems.
• Maintain microbial culture collection and reference strains.
• Ensure calibration and qualification of lab instruments (incubators, autoclaves, laminar airflows, microscopes).
• Ensure proper handling, disposal, and biosafety practices for microbial cultures.
• Train production and quality staff on microbiological hygiene and aseptic practices.
• Contribute to continuous improvement of contamination control strategies.
• Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations.