Quality Control Microbiologist

3 days ago

Hyderabad Telangana, India AMSSO Full time

**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: ₹14,000.00 - ₹25,000.00 per month

Work Location: In person

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