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Chief Microbiology Specialist

2 weeks ago

Guntur, Andhra Pradesh, India beBeeMicrobiologist Full time ₹ 5,00,000 - ₹ 10,00,000

Our organization seeks an experienced and skilled Microbiologist to fill a challenging role.

Job Title: Senior Microbiologist

Job Summary:

A senior microbiologist is required to perform environmental monitoring, sampling, and testing of purified water and raw water. The incumbent will also be responsible for performing microbial limit tests, BET, sterility testing, and supporting cleaning validation by performing swab/rinse microbiological analysis.

  • Main Responsibilities:
  • Environmental Monitoring: Conduct regular environmental monitoring of classified areas (air, surfaces, and personnel) to ensure aseptic conditions.
  • Sampling and Testing: Perform sampling and testing of purified water and raw water.
  • Microbial Limit Tests: Conduct Microbial Limit tests, BET, Sterility testing etc of water, API's and KSM's.
  • Cleaning Validation: Support for cleaning validation by performing swab/rinse microbiological analysis.
  • Microbiological Validation Studies: Conduct microbiological validation studies (e.g., filter integrity testing, media fills for aseptic processes).
  • Qualification of Controlled Areas and Equipment: Participate in qualification of controlled areas, equipment, and utilities (HVAC, water systems, compressed air).
  • Documentation: Prepare and review Standard Operating Procedures (SOPs), protocols, and reports.
  • Data Integrity: Maintain accurate microbiological records as per GMP and data integrity requirements (ALCOA+ principles).
  • Regulatory Compliance: Support regulatory inspections and customer audits and respond to microbiology-related queries.
  • Root Cause Analysis: Participate in out-of-specification (OOS) or out-of-trend (OOT) investigations related to microbial results.
  • Corrective and Preventive Actions: Perform root cause analysis and propose corrective and preventive actions (CAPA).
  • Risk Assessment: Conduct microbiological risk assessments of processes and systems.
  • Culture Collection: Maintain microbial culture collection and reference strains.
  • Lab Instrument Calibration: Ensure calibration and qualification of lab instruments (incubators, autoclaves, laminar airflows, microscopes).
  • Biosafety Practices: Ensure proper handling, disposal, and biosafety practices for microbial cultures.
  • Training and Development: Train production and quality staff on microbiological hygiene and aseptic practices.
  • Continuous Improvement: Contribute to continuous improvement of contamination control strategies.
  • Staying Updated: Stay updated with pharmacopeia changes, ICH guidelines, and regulatory expectations.