+919*********

adlsns@r.postjobfree.com

https://www.linkedin.com/in/dipak-navathar-b230ab3a

Career Objective

To work in a globally competitive, highly dynamic and proactive environment on challenging assignments that shall yield twin benefits of job satisfaction and a fast track professional growth.

Experiences: 8 Years

Currently Working as Site CSV Lead at Lupin Ltd., Aurangabad (Since May 2020)

2.5 Yrs as CSV Executive in Corporate QA at USV Pvt. Ltd., Mumbai (Mar 2018-May 2020)

2.5 Years in Qualification/ Validation/ CSV at Mylan Ltd., Nashik (Sep 2015–Mar 2018)

1.5 Years as QA Officer at Accutest Research Lab., Mumbai (Apr 2014 – Aug 2015)

Projects Handled

Gap Assessment, QRM & Remediation

CSV Implementation at Site- SOP, VMP, GDPNS, WI

CDAS & Serialization (CSV Perspective)

SAP S/4 HANA (MM, PP, QM, PM, WM, SD, HR, FI, CO)

Standalone (Mfg & QC) Systems, Server-client Systems, Enterprise Systems (DMS, LMS)

QAMS (Caliber & Trackwise), Empower, Chromeleon, TIAMO2.4, Stability, Mastersizer, Labsolutions, Zenon, Elipse, Stability, PiSCADA, MVS, etc.

Skills

CSV, GAMP5, 21 CFR Part 11, EU Annex 11, CSA, Certified HP QTP & HP ALM

SOP, QMS, DMS, SAP, Trackwise, GxP, QA, IT-Compliance, Qualification, Validation, Audit

Data Integrity, ALCOA++

Qualification

M. Pharm. (QA)- University of Pune- 2012- 70 %

MBA (Mfg. Mgmt. Distance)-YCMOU- 2018- 71% (8.5 CGPA)

B. Pharm.- 2010- 67% D. Pharm.- MSBTE- 2007- 79% D IPR Law- 2012- 69%

Achievements

Qualified Drug Inspector Examination, 2015 conducted by UPSC for CDSCO

Qualified All India GPAT (GATE) 2010

Author of book published on M. Pharm. Thesis by LAP Publishing House, Germany.

Personal Details

Date of Birth

Feb 03, 1988

Language Known

English, Hindi & Marathi

Marital Status

Married

Total Experience

8 Yrs Industrial + 1.5 Yrs Teaching

Declaration

I undersigned, certify that all the information provided is true to the best of my knowledge and beliefs.

Place: Aurangabad Yours Sincerely,

Mr. Dipak N.

DIPAK

NAVATHAR

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