Sr. Executive- Microbiology

1 day ago

Ahmedabad, India Redox Scientific Full time
  • Supervise and execute routine microbiological testing of raw materials, APIs, water, environmental monitoring, and personnel hygiene.
  • Oversee the qualification, calibration, and maintenance of microbiology lab equipment (e.g., autoclaves, incubators, LAFs, particle counters).
  • Review and approve microbial test reports and ensure timely release of results.
  • Manage environmental monitoring programs (cleanroom, gowning areas, etc.) including alert/action limit trending.
  • Monitor and trend data for microbial limits, endotoxin, bioburden, and water system testing (WFI, purified water, etc.).
  • Conduct microbiological validations and qualifications including method validations, media fill (aseptic process simulation), disinfectant efficacy studies, and microbial identification.
  • Handle and investigate out-of-specification (OOS), deviation, and non-conformance reports related to microbiological testing.
  • Maintain GMP documentation – SOPs, STPs, protocols, reports, logbooks.
  • Support regulatory audits (USFDA, MHRA, WHO, etc.) and customer inspections
  • Compliance: Ensure all microbiological practices comply with cGMP, GLP, ICH, and regulatory standards.
  • Equipment Handling: Operate, calibrate, and maintain microbiological instruments like Laminar Air Flow, Incubators, Autoclaves, Colony Counters, and Sterility Isolators.
  • Train and mentor junior microbiologists and ensure adherence to lab safety and compliance practices.
  • Audit Readiness: Support internal and external audits by maintaining proper documentation and following quality practices.
  • Coordination: Collaborate with QA, Production, and Engineering teams for deviation investigations, CAPAs, and change controls involving microbiological aspects.

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