Laboratory Microbiologist Position

3 days ago

Ajmer, Rajasthan, India beBeeMicrobiologist Full time ₹ 12,00,000 - ₹ 17,00,000

Key Responsibilities:

Environmental Control

  • Maintain aseptic conditions by performing environmental monitoring of classified areas (air, surfaces, and personnel).

Sampling and Testing Protocols

  • Sample and test purified water and raw water to ensure quality standards.
  • Conduct Microbial Limit tests, BET, Sterility testing etc of water, APIs, and KSMs to identify potential contaminants.

Support Functions in Validation

  • Support cleaning validation by analyzing microbiological data from swab/rinse analysis.
  • Conduct microbiological validation studies (e.g., filter integrity testing, media fills for aseptic processes) to assess equipment performance.

Qualification and Training Requirements

  • Maintain accurate records as per GMP and data integrity requirements (ALCOA+ principles).
  • Support regulatory inspections and customer audits by providing microbiology-related expertise.
  • Train production and quality staff on microbiological hygiene and aseptic practices to minimize risks.

Responsibilities for OOS/OOT Investigations

  • Participate in investigations related to microbial results that are out-of-specification (OOS) or out-of-trend (OOT).
  • Perform root cause analysis and propose corrective and preventive actions (CAPA) to resolve issues.
  • Conduct microbiological risk assessments of processes and systems to identify vulnerabilities.

Maintaining Laboratory Expertise

  • Ensure calibration and qualification of laboratory instruments (incubators, autoclaves, laminar airflows, microscopes).
  • Promote proper handling, disposal, and biosafety practices for microbial cultures.
  • Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations to maintain compliance.

Essential Qualifications

  • Bachelor's or Master's degree in Microbiology, Biotechnology, or a related life science field is required.
  • A minimum of 2-4 years of experience in the API/Pharmaceutical industry is expected.

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