Handling of Microbiology method development, method validation, Microbial limit test, growth promotion test, Environmental monitoring, disinfectant efficacy studies.Responsible to lead the microbiology team, troubleshooting in the validations and day to day activities.Hands on expirence in microbial analysis of raw materials, finished products, I process samples, cleaning validation samples, water analysis, isolate identification, autoclave operation, temperature monitoring of incubators,handling of microbial cultures, isolate management and trends preparation.Having in experience of instrument qualification/validation of water system, steam sterilizers and investigation (Laboratory incident, deviation, out of specification), Change control and CAPA management.

Syngene is a contact research manufacturing with biologics products, bulk API manufacturer, injectable manufacturer and oral, solid manufacturer). Working as a QC Microbiologist and Handling of water team in the microbiology department, Preparation of trends and participate in the regulatory and client audits as Subject matter expert for pharmaceutical water system (Microbiology front).Handling of Out of specification, deviation, Laboratory incidents. Involved in Major regulatory inspections USFDA, MHRA, TGA, EMA and various client audits.

Cipla is a bulk API manufacturer (Oncology products) and responsible to Perform all microbiology analysis in the Quality control Microbiology lab.

Worked as a Microbiologist and responsible for, 1. Media preparation and Growth promotion test.2. Handling of media, Bioball and Biological indicators inventories.3. Stasis test for Media fill vials.4. Water sampling and water analysis for Source water, Raw water, purified water, water for injection and pure steam condensate.5. Isolate identification and isolate library management.6. Trend and summary report preparation for water samples.7. Evaluation of alert and action limit for water and environmental monitoring samples.8. Pre-qualification of Bioball, biological indicators and isolate identification cards.9. Execution of disinfectant efficacy test.

Caplin point laboratories is a sterile injectable manufacturer (liquid filling and optalmic products), 1. Responsible for Environmental monitoring in production, ware house and microbiology lab clean rooms.2. Preparation of trend charts.3. Qualification of employees in clean room by gowing qualification and involved in Aseptic process simulation.4. Executed extended exposure and incubation of environmental monitoring plates.5. Executed sterilized Garments hold time to study in a clean room.6. Handling of online viable remote air samplers to monitor class 100 environment.