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Lab qa manager/micro manager

Location:
Ahmedabad, Gujarat, India
Posted:
July 08, 2021

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Resume:

RESUME

Mr. Santosh.B.Koli adnmb4@r.postjobfree.com

Mobile : 079********

Objective: To be creative part of growing industry and work with full of my abilities and utilize my

Skills in the field of research/production in microbiology and its allied areas.

Current Occupation:

Presently working as Asst. Manager Zydus Cadila OSD & Injectable since Oct.2016 to till date.

Priory worked as Section Head-Management Cipla Injectable since Sep.2014 to Aug.2016.

Prior to this worked as Asst. Manager Quality Mediplas Lab Since May 2012 to Sep.2014.

Prior to this working as Asst. Manager QC Microbiology Naprod Life-Sciences, Pvt Ltd., (Injectable) Since Dec.2010 to April.2012.

Prior to this worked as a Research associate Band 1B in Nicolas Piramal Pharma R&D Centre, Ahmedabad, since Jan.2009 to Dec 2010.

Prior to this worked as a Research Officer in Sun Pharma R&D center, (Injectable)

Baroda since March 2004 to Jan.2009.

Prior to this worked as a Research Officer in Solaris Biochemical R&D center,

Baroda since March 2003 to March 2004.

FDA Approval – Microbiology & Sterility of Maharashtra State & Microbiology of Gujarat State

Job Responsibilities at Zydus Cadila & Cipla, Goa (Injectables):

Job Allocations to sub-ordinates

Clean Room Area evaluation with Prospective of Microbial contamination.

Risk assessment with prospective of Microbial contamination to Product exposure.

Documentation as per GLP/cGMP

Method demonstration (BET/Sterility/MLT/Compressor Air Sampling with consideration of area contamination.)

Internal / International Audit preparations.

OOS/OOT/OOACs/Deviations- Investigation.

Environmental Monitoring & Gowning Qualification

Job Responsibilities at Mediplas Lab (Sterile medical devices)

Job Allocations to sub-ordinates

Documentation as per GLP/GMP

Preparation of SOP/STP, Training/ Method demonstration.

Job Responsibilities at Naprod Life Sciences (Injectables)

Job Allocations to sub-ordinates

Documentation as per GLP/GMP

Preparation of SOP/STP, Training/ Method demonstration

Internal / International Audit preparations

Job Responsibilities at Sun Pharma Research Centre (Injectables /ADL/F&D)

Bacterial endotoxin test.

Sterility test.

Preservative efficacy Test.

Method development and Validation.

Microbial Limit Test.

Method development and Validation.

Antibiotic / Vitamin Assay

Method development and Validation.

Maintenance of microbial cultures.

Environmental Monitoring & Gowning Qualification

Job Responsibilities at Nicolas piramal Pharma Research Centre

Environmental monitoring,

Water analysis

MLT, Bio-burden Test, and method validation.

Documentation, Preparation for the Internal and External Audits etc.,

Previous Experience

Worked as R&D Microbiologist in Solaris Biochemicals, (Citric acid fermentation industry)

Jambusar, Baroda from March 2003 to Feb 2004.

Job Responsibilities at SOLARIS BIOCHEMICALS, BARODA.

Optimization of nutrient concentration of fermentation media through shake flask, pilot fermentation.

Culture transfer and strain development by single colony isolation method.

Inoculum preparation, Sub-culturing & maintenance.

Spore propagation and Stock preservation.

Educational Qualification:-

M. Sc. Microbiology : (2000-2002)

References: -

Dr. Brajesh Thakur, Dy. General Manager- ADL- Zydus Cadilla PTC-Ahmedabd

Cell no. 081********

Dr. Sudeep ozha Dy. General Manager - ADL- Zydus Cadilla PTC-Ahmedabd

Cell no. 760*******

Mr. Mahesh Kulkarni QA Head, Cipla pharma Ltd Unit V Goa. Mo: 097********

Mr. Vinayak Gaonkar Micro Head, Cipla Goa Facility. Mo: 097********

Dr. K. Shivram (office)- : 026*-*******

Vice President, Sun Pharma Ltd, Baroda.

Thanks

Santosh B Koli

Cell no.: 797-***-****.



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