Quality Control Microbiologist

1 week ago

Hyderabad, Telangana, India AMSSO Full time ₹ 1,68,000 - ₹ 3,36,000 per year

Job Purpose:

To ensure microbiological testing, monitoring, and documentation of products, raw materials, water systems, and environmental samples in compliance with cGMP, GLP, and regulatory standards (USFDA, MHRA, WHO-GMP, etc.).

Key Responsibilities:1. Routine Microbiological Testing

  • Perform microbial limit test, sterility test, endotoxin test (LAL/Gel clot/Turbidimetric method).
  • Conduct water testing (Purified water, WFI) and environmental monitoring.
  • Handle microbial identification using biochemical and automated systems (e.g., VITEK, API, MALDI-TOF).
  • Perform growth promotion test (GPT) for media used in testing.
  • Conduct bioburden testing for in-process and finished products.

2. Environmental and Utilities Monitoring

  • Perform viable and non-viable particulate monitoring in manufacturing and aseptic areas.
  • Conduct compressed air and surface monitoring.
  • Monitor and trend environmental data to ensure compliance with cleanroom standards (ISO 5–8).

3. Documentation & Compliance

  • Maintain accurate and complete microbiological records, logbooks, and test reports.
  • Ensure compliance with cGMP, GDP, and company SOPs.
  • Participate in internal/external audits and support CAPA implementation.

4. Instrument Handling & Maintenance

  • Operate, calibrate, and maintain lab instruments such as Laminar Air Flow, Autoclave, Incubator, BOD, and Particle Counter.
  • Participate in instrument qualification (IQ/OQ/PQ).

5. Method Validation & Troubleshooting

  • Participate in microbiological method validation and media validation.
  • Investigate out-of-specification (OOS) and deviations related to microbiological activities.

6. Team & Training

  • Train junior analysts on microbiological techniques and SOPs.
  • Support continuous improvement initiatives in the QC department.

Key Skills & Competencies:

  • Strong understanding of microbiological techniques and aseptic practices.
  • Familiar with regulatory guidelines (USFDA, EU, WHO, MHRA, PIC/S).
  • Good documentation and data integrity practices.
  • Proficient in MS Office and LIMS systems.
  • Excellent attention to detail and teamwork.

Education Qualification:

  • B.Sc. / M.Sc. / M.Tech. in Microbiology, Biotechnology, or Life Sciences.

Job Types: Permanent, Fresher

Pay: ₹14, ₹25,000.00 per month

Work Location: In person

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