Nirav Shah

Current Role: Serving as Sr. Executive at RPG Life Sciences from September. From 2017 to the present, I lead a team of five microbiologists in the Microbiology department.

Audit Experience: Extensive exposure to various audits, including TGA, EU-GMP, WHO, and other regulatory requirements and compliance.

System Expertise: Proficient in using and operating SAP (basics), LMS, DMS, EQMS, and various instrument-related software.

Documentation: Expertise in designing SOPs, qualification protocols, and method validation protocols for the microbiological department.

Quality Management System (QMS): Adapt in investigations, Out of Specifications (OOS), Out of Calibration (OOC), Lab Incidents (LI), Quality Risk Management (QRM), Deviation, and Corrective and Preventive Actions (CAPA) through the change control procedure (eQMS).

Communication and collaboration: Strong communicator with experience in cross-functional team interaction, including production, packing, QA, and QC departments.

Microbiology Department Management:

Independently oversee all the functions of the Microbiology department, including the planning and execution of activities from sampling to the release of raw materials, finished products, and water analysis samples. Also, culture maintenance, media preparation, qualification and GPT, environment monitoring of classified areas, periodic performance qualification of lab equipment, scheduled calibration of instruments, failure investigations with QMS tools, and handling the audits for the microbiology laboratory.

Validation: Designing the protocol for the microbiology department for the hold time study of microbiological media, plate exposure hold time, disinfectant hold time study, and its execution in adherence with the regulatory requirements.

Instrument management: User Requirement Specification (URS), procure, qualify, and maintain the equipment/instrument. Ensure the adherence to the calibration schedule and equipment maintenance periodically.

Projects: Setting up a new microbiology laboratory, including lab design, procurement of equipment and instruments as per laboratory requirements, along with designing SOPs, area qualification, and temperature mapping.

Personnel Training: Conducting the training related to SOPs and any other regulatory training, and providing the same training to the below analyst.

Working as an Analyst in Microbiology for testing the water sampling, analysis, and release activity to SAP. MLT analysis, RM analysis, and environmental monitoring of the microbiology laboratory and production area.

In this tenure, I tried to learn about the pharmaceutical industry, as this was my first organization in my career. So, in this organization, I started my career with media preparation, pH balance calibration and verification, HPHV steam sterilizer operation and its periodic qualification, and vertical autoclave operation and its periodic qualification. Along with culture handling, BOD incubator handling, and operation of ThermoLab software to manage the audit trail of the BOD incubator in the Microbiology department. Followed by sampling and testing of purified and potable water, finished product testing, raw material testing, periodic performance qualification of equipment, calibration of instruments, etc.

Along with this environment monitoring of controlled area was done as per guidline for production area and microbiology department.