Sr. Executive- Microbiology

Redox Scientific

6 - 10 years

5 - 10 Lacs

ahmedabad

Posted:5 hours ago| Platform:

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Skills Required

bioburden documentation skills api endotoxin water system validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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