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Profile Details
Create Project
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USD 15 /hr
Hire Vishalbhai N.
India
USD 15 /hr

Good Clinical Practice (GCP) & CSV Consultant/Freelancer & auditor with 18 years of experience

Profile Summary
Subject Matter Expertise
Services
Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing
Research User Research, Feasibility Study, Technology Scouting
Consulting Digital Strategy Consulting, Healthcare Consulting, Regulatory Consulting
Data & AI Statistical Analysis
Work Experience

Project Management

Troikaa Pharmaceutical Ltd.

September 2024 - August 2025

Head Quality Assurance, Clinical trials

Veeda Clinical Research Ltd.

September 2022 - September 2024

Head - Quality Assurance - Clinical Trials

Veeda Clinical Research Ltd

September 2022 - September 2024

Sr. Manager - Quality & Compliance - Late Phase & Early Phase Clinical Trials

Zydus Lifesciences Ltd.

March 2017 - September 2022

Sr. Manager - Clinical Research and Development

Zydus Lifesciences Ltd.

March 2017 - September 2022

Team Lead , Quality Assurance

Lambda Therapeutics Research

February 2015 - February 2017

Team Lead – Quality Assurance (IT/CSV, GCP, GCLP, GLP)

Lambda Therapeutic Research (India)

February 2015 - February 2017

Scientist II – Corporate Quality Assurance (GCP and GLP auditor)

Torrent Research Centre

September 2008 - February 2015

Scientist II, Corporate Quality Assurance (GCP and GLP auditor)

Torrent Research Centre

September 2008 - February 2015

Research Scientist - QA

Alembic Pharmaceuticals Limited

January 2007 - September 2008

Research Scientist -Quality Assurance - Clinical Trials

Alembic Pharmaceuticals (India)

January 2007 - September 2008

Education

MBA

Sikkim Manipal University

May 2013 - May 2015

Master of Pharmacy

Sardar Vallabhai Patel University

May 2005 - May 2007

Bachler of Pharmacy

Sardar Patel University

May 2001 - May 2005

Certifications

  • Registered Quality Assurance professional - Good Clinical Practice (RQAP-GCP)

    Society of Quality Assurance (SQA)

    September 2024 - Present

  • Guardian of Quality

    Zydus Lifesciences ltd.

    July 2019 - Present

  • GCP trainer

    Zydus Lifesciences ltd.

    January 2019 - Present

Publications