
Senior Laboratory Scientist
1 week ago
Job Opportunity:
- We are seeking an experienced Microbiologist to join our team.
- The ideal candidate will have a strong background in microbiology and experience in the API/Pharmaceutical industry.
Key Responsibilities:
- Conduct environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
- Perform sampling and testing of purified water and raw water.
- 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.
- Investigate out-of-specification (OOS) or out-of-trend (OOT) results related to microbial samples.
- 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).
- Implement 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.
Requirements:
- Bachelor's/Master's degree in Microbiology, Biotechnology, or any Life sciences domain.
- Minimum 2-4 years experience in API/Pharmaceutical industry.
Skills:
- Environmental monitoring
- Microbial testing
- Validation studies
- Standard operating procedures
- Data integrity
- Regulatory compliance
- Contamination control
- Laboratory instrumentation
- Biosafety practices
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