Result driven professional working in pharmaceutical industry having 13+ years of experience in and Validation within stipulated time and quality norms.
Overview
14
14
years of professional experience
Work History
Sr.Executive - (QC-Microbiology)
Alembic Pharmaceuticals Ltd.
Vadodara
12.2017 - Current
Company Overview: Alembic is USFDA Approved sterile manufacturing Unit located in Vadodara.
Responsible for verified and Reviewed Laboratory documents in LIMS, E logbook,Daily calibration, Analysis document (MLT analysis & Bioburden analysis of Inprocees samples, stability samples, Finished, Packing materials), review of Summary reports.
Responsible for Microbiology Laboratory planning, execution and completion of Monitoring, Analysis and Validation within stipulated time and quality norms.
Responsible for training and certification to Microbiologist.
Responsible for preparation of Standard Operating Procedures and all quality related documents like Specification, Standard Test Procedure etc.
Responsible for Investigate and closure of Incident in Microbiology laboratries.
Responsible for Preparation of Analytical method validation protocols and reports.
Having exposure of various regularly audits like USFDA, TGA, MHRA, WHO.
Having exposure of Instrument and Equipment Qualification i.e. LAF and Biosafety Cabinet, Dynamic, Autoclave, nonviable monitor.
Having expertise in various microbiology methods and it's validation i.e. MLT, BET, Sterility, Microbiology.
Executive - (QC-Microbiology)
Lupin Pharmaceuticals Ltd
Pithampur
01.2015 - 12.2017
Company Overview: Lupin is an USFDA, MHRA approved Sterile Manufacturing Unit Located in Pithampur.
To Perform Water Chemical analysis & Microbial analysis.
Environment monitoring.
To perform Bacterial Endotoxin Test of Raw materials.
To perform Microbial Limit Test of Raw materials, Finished product and stability samples and analysis of Water samples etc.
Media Preparation and performing of GPT.
Lupin is an USFDA, MHRA approved Sterile Manufacturing Unit Located in Pithampur.
Officer - (QC-Microbiology)
Cipla Pharmaceuticals Ltd
Goa
03.2013 - 12.2014
Company Overview: Cipla is an USFDA, MHRA, TGA approved Sterile Manufacturing Unit Located in Goa.
To perform Bacterial Endotoxin of Water samples WFI and Pure Steam.
To perform Microbial Limit Test and Bioburden Test of In-Process samples, Raw materials, packing materials, Water samples.
To perform Environment Monitoring (Settle plate, Active air sampling, Passive air sampling, surface monitoring, Personal monitoring).
To perform Water Sampling of Purified Water, Source Water, Drinking Water, Water for Injection and Pure Steam.
Culture and Inoculum Preparation.
Cipla is an USFDA, MHRA, TGA approved Sterile Manufacturing Unit Located in Goa.
Officer - (QC-Microbiology)
Ciron Drug Pharmaceutical Ltd
Bhohisar
08.2012 - 02.2013
Company Overview: Ciron Drug Pharmaceutical Ltd is an WHO approved Sterile Manufacturing Unit Located in Bhohisar.
To perform Water Sampling and analysis of Purified Water, Source Water, Drinking Water, Water for Injection and Pure Steam.
Media Preparation and performing of GPT.
Environment monitoring.
Ciron Drug Pharmaceutical Ltd is an WHO approved Sterile Manufacturing Unit Located in Bhohisar.