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1 day ago
We are seeking a skilled Microbiologist to join our team.
Required Skills and Qualifications- M.Sc/B.Sc. in Microbiology, Biotechnology or any Life sciences domain
- 2 to 4 years experience in API/Pharmaceutical industry
- Perform environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions
- Sampling and testing of purified water and raw water
- 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)
- 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
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