Pramod Hiremath Email & Phone Number

Karnataka, India

Bengaluru, Karnataka, India

✓ Involved in Biological Products contamination check.✓ Performed microbiological testing of raw materials, in-process products, bulk products, finished products, and purified water for product release in a timely manner. ✓ Sampled, tested, and approved all incoming raw materials.✓ Routine disinfectant preparation lab equipment cleaning/area cleaning.✓ involved in swab sampling of manufacturing accessories.✓ Six Sigma white belt certificate completed.✓ Involved in the biological indicator enumeration / testing/incubation/observation.✓ handled PTS instrument for bacterial endotoxin test.✓ Handled SAP MM Module - PR requisition_ Purchase order_vendor invoice_GRN in SAP_Gate entry_Goods receipt_Quality release _MIRO.✓ Team handling,time management, TAT achievement, hurdles solving, identify gap assessment.

Dharward, Karnataka, India

>QC Microbiologist.✓ Water systems, Equipment's qualification and aseptic media fill studies.✓ Classified area qualification & Re-qualification in static and dynamic conditions.✓ Potable Water ,Purified water and water for injection (WFI) distribution system, Pure Steam qualification in phases.✓ URS, SLIA Preparation and Approval.✓ IQ, OQ, PQ and Revalidation of direct impact and indirect impact equipment's like , Steam sterilizer (Autoclave), Dry heat sterilizer, Steam pot , water bath , oven , dynamic pass box, static pass box, SAS air sampler , non viable particle count. Mobile LAF, Bio safety cabinets.✓ Environment monitoring program execution, trends report preparation, Gowning Qualification , and Re-qualification, VPC & NVPC Routine execution , trend annual summary.✓ Conducting aseptic media fill study trails for 2ml, 10ml ,100ml vial filling, PFS Filling and sealing lines.✓ Media fill vials,PFS Visual inspection.✓ Data logger operation and temperature mapping, data generation.✓ Water Analysis (pathogens & TVC) ,Swab Analysis ,Bioburden analysis.✓ Bacterial Endotoxin Test for wash water ,Pure Steam , Water for injection.✓ Consumable order and maintaining excel sheet for stock.✓ Swab hold time study, Water hold time study.✓ QMS - Out of specification, out of limit (alert , action limit), Change control, deviation, SOP Preparation & revision, Laboratory incident, investigation- CAPA.

Bangalore Urban, Karnataka, India

•QC Microbiology- Executive✓ SAP Handle in MM module - PR requisition_ Purchase order_vendor invoice_GRN in SAP_Gate entry_Goods receipt_Quality release _MIRO.✓ Water Sampling , Environmental Monitoring, Trend Preparation, ✓annual summary for Environmental Monitoring, area qualifications. ✓ table top equipment/instruments Qualifications, Water system qualifications.✓ Media preparation, GPT, Autoclave handling, pH meter, weighing balance calibration.✓ Microbial limit Test , Bacterial endotoxin test.✓ Incubator qualifications. handling of SAP, LIMS.✓ Handing Biological indicator (strips, ampules, disc)✓ Raw material sampling, Raw material testing✓ Out of specification, Out of Limit - investigation , Incident Handling, Deviation, CAPA Handling.