Deputy Manager - Microbiology

Role & responsibilities

1. Product Testing

• Sterility testing in accordance with pharmacopeial, ISO standards and internal procedures.

• Bioburden testing for in-process and finished products.

• To develop & Carry out Bacterial Endotoxin Tests (BET) using gel clot or kinetic methods (LAL test).

• Preparation, document, and execute microbiological test method validations.

2. Environmental Monitoring (EM)

• Routine environmental monitoring of controlled areas including viable (air, surface, personnel) and non-viable particulate monitoring, as required.

• Preparation of data-trend of EM results, and escalate and take / recommend appropriate actions in any deviations or out-of-trend results.

• Investigations for EM excursions and deviations.

3. Water Testing

• Microbiological testing of purified water (PW) and other utilities as required.

• Monitoring water systems for microbial limits, endotoxins, and test reports where required.

• Maintain sampling records and trend reports.

4. Cleaning Validation

• Microbiological evaluation of cleaning validation including swab sampling and rinse analysis.

• Methods are suitable for microbial recovery from cleaned surfaces.

• Documentation and reporting of results as part of cleaning validation protocols.

5. Instrument Calibration & Validation

• Timely calibration and performance checks of microbiological lab instruments (incubators, autoclaves, particle counters, etc.).

• Qualification and validation activities (IQ/OQ/PQ) for production and lab instruments/ equipment.

• Maintenance of equipment logs and ensure adherence to calibration schedules.

6. Failure Investigations

• OOS (Out of Specification), OOT (Out of Trend), and deviation investigations related to microbiological testing to identify its cause and propose/implement corrective actions.

• Ensure regulatory compliance requirements.

7. Documentation & Compliance

• Ensure accurate and timely documentation of test results in laboratory notebooks and systems.

• Prepare/review SOPs, protocols, and reports.

• Adherence to GMP, GLP, and GDP standards.

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