Quality Control (Sterility Testing)
- BVR
- 1 - 5 years
- 4 months ago
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Job Description
Role & responsibilities
Sterility Testing & Microbiological Analysis
- Perform sterility testing of finished products, intermediates, media, and utilities as per pharmacopeial requirements (IP / USP / EP).
- Conduct sterility testing using membrane filtration and direct inoculation methods.
- Perform microbial limit tests (MLT), bioburden testing, endotoxin testing (LAL), and environmental monitoring as required.
- Handle and monitor sterility test isolators, laminar airflow systems, and cleanroom environments.
Environmental Monitoring & Cleanroom Control
- Execute routine environmental monitoring (air, surface, personnel) in classified areas.
- Trend and evaluate EM data to identify deviations and implement corrective actions.
- Support cleanroom qualification, requalification, and validation activities.Audits & Regulatory Support
- Support internal, customer, and regulatory audits (WHO, DCGI, USFDA, EMA, etc.).
- Provide microbiological data and justifications during inspections.
- Ensure readiness of microbiology lab for audits and inspections.
Equipment & Media Handling
- Ensure proper preparation, sterilization, qualification, and storage of culture media.
- Perform growth promotion tests (GPT) and media validation.
- Maintain and calibrate microbiology laboratory equipment as per schedule.
Regards,
Dhivakar D
dh*****r@bv**c.com
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Production & ManufacturingRole: QC MicrobiologistEmployement Type: Full timeContact Details:
Company: BVRLocation(s): Ambarnath+ View Contact
Keyskills: MLT Sterility Testing clean room control Equipment Handling LAL GPT
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