Saurabh Vishwakarma

Manager

About

Experience in formulation & API with exposure in Quality control microbiology with achievements and records for successfull USFDA,TGA, MHRA & various MOH (France,Korea) audits,complete quality system development and all time compliance. Specialties:Current project:- Biosimilar injectable greenfield Micro setup, Validation,Investigation,Quality management system, CAPA & QRM.

Country

India

City

Bhopal

Industry

Pharmaceuticals

Skill

Microbiology, Validation, Corrective and Preventive Action (CAPA), QRM, Investigation, Root Cause Analysis, cGMP practices, Good Laboratory Practice (GLP)

Experience

Manager

ERIS Bionxt

2021-2 - Present · 5 yrs 8 mos

Bhopal, Madhya Pradesh, India

Green field project of Biosimilar product

Manager

Ipca Laboratories Limited

2016-7 - 2021-2 · 4 yrs 8 mos

EDQM Approve.

Asst. Manager

Glenmark Pharmaceuticals

2015-12 - 2016-7 · 8 mos

Anklesvar, Gujarat, India

USFDA approved.

Sr. Executive

Alembic Pharmaceuticals Limited

2014-11 - 2015-11 · 1 yr 1 mo

Vadodara, Gujarat, India

EDQM & USFDA approved.

Officer

Teva Pharmaceuticals

2011-11 - 2014-11 · 3 yrs 1 mo

Gwalior Area, India

Mfg of Generic API, TGA & USFDA approved.

Executive

Symbiotec Pharmalab Limited

2011-2 - 2011-11 · 10 mos

Indore, Madhya Pradesh, India

Mfg of cortico-steroids, WHO -GMP and US-FDA approved. Reviewing water validation. Implementing GMP & GLP in the laboratory. Review and updating of specifications, SOP's. Calibrations & DQ/IQ/OQ/PQ. Validation of all new instruments. AHU validation.

Sr.officer microbiologist

Aristo Pharmaceuticals Pvt. Ltd.

2007-8 - 2011-2 · 3 yrs 7 mos

Preparation of SOP's, protocol & specifications. Routine calibration of instruments as par GLP. Review of sop's & format. Microbiological analysis of finished products, R M, purified water & distilled water, & MLT validation Sterility testing of raw materials & finished products, & Sterility validation. Environment monitoring of clean rooms by various methods as per schedules, & area validation. Autoclave validation. DHS validation. Media fill validation. Water validation

Microbiologist

Choksi Laboratories Ltd.

2006-6 - 2007-8 · 1 yr 3 mos

Executive 'A' Microbiological analysis of pharmaceuticals raw material & finished products and beverages, purified water, distiledl water and their respective specification and method of analysis. Sterility testing, antibiotic & vitamine assays. Maintainance of all record equipment to be used in analysis in working & calibration. Participate in all training. Interlaboratory/ proficiency testing events planned by laboratory. Procument, preparation & maintenance of master, stock & work culture. Preparation of volumetric solution, media, reagents & for analysis, from time-to-time. Purchase requisition indent & materials receipt for micro division. Carry out all necessary tasks as may be required to perform normal duties as an senior microbiologist & deputee to the in charge in drug & chemical divison.

chemist

Inven pharmaceuticals pvt. Ltd

2004-11 - 2006-5 · 1 yr 7 mos

Environment monitoring of clean room. Sterility testing of large & small volume. Culture maintainance. Chemical testing of bulk & finished products. Testing of physical materials used in large volume. IPQA activity, line clearance & BMR prepretion. Microbial analysis of water samples.