
Experienced Life Sciences Professional
12 hours ago
Job Title: Microbiologist
Description:
We are seeking an experienced Microbiologist to join our team. As a Microbiologist, you will be responsible for conducting environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
The ideal candidate will have a strong background in microbiology and experience working in a similar role.
Responsibilities:
- Perform environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
- Sample and test purified water and raw water.
- Perform microbial limit tests, BET, sterility testing etc of water, API's and KSM's.
- Support 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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