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Quality Control (Sterility Testing) @ BVR

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 Quality Control (Sterility Testing)

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 Sciences
Functional Area / Department: Quality Assurance
Role Category: Production & Manufacturing
Role: QC Microbiologist
Employement Type: Full time

Contact Details:

Company: BVR
Location(s): Ambarnath

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Keyskills:   MLT Sterility Testing clean room control Equipment Handling LAL GPT

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