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Manufacturing Audit

October 19, 2016

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Mr.Nitin B Chapulkar


Mobile: +91-940*******,738-***-****


Career objective :

A challenging position in an esteemed organization that will benefit from my initiative, capabilities and contribution. I am especially interested in a position with the potential for advancement and increased decision-making responsibilities.

Industrial Experience:-

Current working with Mylan Laboratories Ltd. Nasik from 04 Feb 2016.

Prevoius experience with Lupin Ltd from August 2009 to August 2015

JOB PROFILE with Mylan Laboratories Ltd :-

To prepare process validation protocol and report.

To prepare and review Risk assessment.

To review BMR, BPR and QC report for batch release.

JOB PROFILE in Lupin Ltd :-

To carry out Inprocess checks as per respective BMR in manufacturing on Online SCADA software.

Process Performance qualification sampling, at various stages. Cleaning validation sampling, Semi finished goods sampling, hold time sampling, Control Sample.

Log book review on online e-log system

Printing of master batch production record in SAP system.

To prepare APQR.

Perform AQL inspections.

Review of online document and IPOOT.

Handling experience about Qc instrument HPLC,UV, IR and dissolution apparatus.

Audit exposure:-

Successfully faced USFDA Audit at Lupin Ltd in March-2015

Successfully prepare for German Audit at Lupin Ltd in February-2015

Successfully faced WHO, TGA, MCC, ANVISA, Audit at Lupin Ltd in June-2013

Successfully Prepared for MHRA Audit at Lupin Ltd in 2013

Successfully Prepared for USFDA Audit at Lupin Ltd in -2009

Academic details:-

Passed B.Pharmacy from MCP Nilanga In June2009 in first class.

MBA from (Manufacturing Operation) YCMU University Nasik.

Personal details:-

DOB: 22 JUNE 1987. SEX: Male status: married

Current CTC: 4.8 L/A EXP CTC: 40%Rise Notice Period: 03 Months


I hereby declare that the information given above is true to the best of my knowledge.

Nitin B Chapulkar

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