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Shiv Narayan Sharma

@shivnarayansharma

Quality Control Reviewer at Teva Pharmaceutical Development Center, reviewing stability and method validation data under cGMP.

What I'm looking for

I’m seeking a quality control specialist role where I can make a qualitative difference and have my competence and skills rewarded for the mutual benefit of the organization and myself.

At Teva Pharmaceutical Development Center, I work as a Quality Control Reviewer, reviewing and approving data for stability studies, method validations, and method transfers. I also handle quality system issues including OOS, OOT, incidents, and deviations.

My work includes implementing cGLP practices, participating in investigations and audits, and preparing stability protocols and summary reports. I use HPLC and LCMS instruments and work with systems including Empower, Chromeleon, and Labsolution.

Experience

Work history, roles, and key accomplishments

TL

Current

Reviewer (Q.C)

Current

Teva Pharmaceuticals Ltd.

Sep 2024 - Present (2 years 1 month)

Working as Quality Control Reviewer at Teva Pharmaceutical Development Center since September 2024, responsible for reviewing and approving data generated at site for stability, method validations, and method transfers.

HPLC Empower 2&3 Chromeleon Class Vice President LC Solution LC MS UV Visible Spectrophotometer Dissolution Apparatus Auto Titrators Polarimeter FTIR QMS OOS OOT CAPA GLP GMP ICH Guidelines FDA MHRA TGA WHO

AP

Quality Control Reviewer

Aurobindo Pharma

May 2020 - Sep 2024 (4 years 4 months)

Worked at Aurobindo Pharma from May 2020 to September 2024, performing quality control duties including review of analytical data and handling QMS issues.

HPLC Empower Chromeleon QMS OOS OOT CAPA GLP GMP

TL

Quality Control

Torrent Pharmaceuticals Ltd.

Jan 2018 - Mar 2020 (2 years 2 months)

Worked at Torrent Pharmaceuticals Ltd. from January 2018 to March 2020, involved in quality control activities.

HPLC Empower Chromeleon QMS GLP GMP

ML

Quality Control

Macleods Pharmaceutical Ltd.

Sep 2014 - Aug 2017 (2 years 11 months)

Worked at Macleods Pharmaceutical Ltd. from September 2014 to August 2017, performing quality control duties.

HPLC Empower QMS GLP GMP

Education

Degrees, certifications, and relevant coursework

VU

VBS Purvanchal University

M.Sc., Chemistry

Completed M.Sc. in Chemistry from VBS Purvanchal University, Jaunpur in 2013.

VU

VBS Purvanchal University

B.Sc., Chemistry

Completed B.Sc. in Chemistry from VBS Purvanchal University, Jaunpur in 2011.

UA

UP Board Allahabad

H.S.C.

Completed H.S.C. from UP Board Allahabad in 2008.

UA

UP Board Allahabad

S.S.C.

Completed S.S.C. from UP Board Allahabad in 2006.

Tech stack

Software and tools used professionally

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

ChemDraw

Availability

Looking for a job

Location

India

Authorized to work in

Salary expectations

100k+ USD

Job categories

Quality Control Reviewer

Skills

Quality Control CGLP GMP GLP Out Of Specification (OOS) Investigations OOT Investigation Root Cause Analysis CAPA Deviation Management Quality Management Systems Stability Studies method validation Method Transfer data review Instrument Qualification (IQ OQ PQ)

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