Role & responsibilities

- Perform microbiological analysis of purified water, potable water, compressed air, nitrogen, and other utility samples as per approved procedures.

- Conduct Environmental Monitoring (EM) of classified manufacturing areas, microbiology laboratories, warehouses, and utility areas using active air sampling, settle plates, contact plates, and surface swabs.

- Perform microbial limit testing and bioburden analysis of raw materials, intermediates, and APIs, wherever applicable.

- Prepare, sterilize, qualify, and maintain microbiological media, reagents, and laboratory solutions.

- Perform Growth Promotion Test (GPT), media qualification, and culture maintenance activities.

- Carry out microbial identification using approved microbiological techniques and maintain reference cultures.

- Perform trend analysis of environmental monitoring and utility monitoring data and report any adverse trends.

- Ensure routine calibration, qualification, verification, and preventive maintenance of microbiology laboratory instruments and equipment.

- Maintain laboratory notebooks, worksheets, logbooks, analytical records,



and electronic data in compliance with ALCOA+ and data integrity principles.

- Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), environmental monitoring excursions, laboratory deviations, and support implementation of Corrective and Preventive Actions (CAPA).

- Ensure compliance with cGMP, GLP, SOPs, EHS policies, and applicable pharmacopeial requirements (USP, EP, IP).

- Coordinate with QA, Production, Engineering, Validation, and Maintenance departments for microbiological investigations and contamination control activities.

- Participate in qualification and validation activities related to cleanrooms, utilities, equipment, and microbiological methods.

- Support internal audits, customer audits, and regulatory inspections by providing microbiology-related documentation and technical information.

- Maintain laboratory housekeeping, biosafety standards, and inventory of microbiological media, reagents, cultures, and consumables.

- Contribute to continuous improvement initiatives to strengthen microbiological controls and laboratory efficiency.

📌 Microbiologist Executive (Vadodara)
🏢 Exemed
📍 Vadodara