
Senior Life Sciences Professional
3 days ago
Job Title: Microbiologist
Job Description:We are seeking a highly skilled Microbiologist to join our team. The successful candidate will be responsible for conducting environmental monitoring, sampling and testing of purified water and raw water, performing microbial limit tests, and supporting cleaning validation.
Required Skills & Qualifications:- Master's or Bachelor's degree in Microbiology, Biotechnology, or a related life sciences field.
- Minimum 2-4 years of experience in the API/Pharmaceutical industry.
- Strong understanding of microbiological principles and laboratory techniques.
- Excellent communication and analytical skills.
- 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.
- Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations.
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