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Sunil Kumar

Sunil Kumar

Project Trainee

Followers of Sunil Kumar2000 followers
location of Sunil KumarAhmedabad, Gujarat, India

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  • Timeline

  • About me

    Assistant Manager I DQA I Ex- Alembic l Ex- Sava Global l Reviewer I QMS I M. Pharmacy l

  • Education

    • Bioinformatics Institute of India, Noida

      2012 - 2013
      Post Graduate Diploma in Drug Regulatory Affair. Drug Regulatory Affair

    • University of Pune

      2007 - 2011
      Bachelor of Pharmacy (B.Pharm.) Pharmaceutical Sciences Distinction, 2nd Ranker in College

      Activities and Societies: Presented Poster in International and National conferences.

    • University of Pune, Padmshri Dr. D.Y. Patil I.P.S.R. Pimpri, Pune

      2011 - 2013
      Master of Pharmacy Quality Assurance Technique

  • Experience

    • GenPharma International Pvt. ltd.

      Sept 2012 - Apr 2013
      Project Trainee

      Analytical Method Development and Validation, I.P.Q.A., A.P.Q.R. Preparation, Specification Review

    • SAVA Research

      Feb 2014 - Oct 2015
      Research Officer

      Stability Study, Routine Analysis, Method development, Validation, Calibration, Documentation

    • Alembic Pharmaceuticals Limited

      Nov 2015 - Nov 2020

      Analytical Development Lab (Formulations) Routine Analysis, Calibration, Stability Study, Documentation, GLP Activities, Project hours calculation, Dose dumping & Multimedia dissolution study

      • Research Scientist

        May 2020 - Nov 2020

      • Research Associate

        Nov 2015 - Apr 2020

    • Auxilla Pharmaceuticals and Research LLP

      Nov 2020 - now

      Research & Development (Quality Assurance).Review of Analytical method development protocols and reports.Review of Analytical method validation protocols and reports.Review of specifications, STP’s, COA’s and analytical data generated at analytical department.Review of technology transfer related documents.Stability Protocol, In Use Stability Protocol Review Self InspectionReview URS, DQ and FAT documents.Ensure timely calibration of Instrument/equipment as per calibration schedule. Show less

      • Assistant Manager

        Sept 2023 - now

      • Senior Research Scientist

        Nov 2020 - Sept 2023

  • Licenses & Certifications

    • Data Integrity

      Research Quality Association (RQA)
      Jul 2021

    • Foundations of GMP: Data Integrity and Computer System Validation

      US Pharmacopeia
      May 2020

    • Dissolution Apparatus Qualification: USP Apparatus 1 and Apparatus 2

      US Pharmacopeia
      May 2020

  • Honors & Awards

    • Awarded to Sunil Kumar
      134 Rank in AUPPC-CET 2011 AUPPC, WARDHA, MAHARASHTRA Jun 2011
    • Awarded to Sunil Kumar
      280 Rank in MH-CET 2011 DTE, MAHARASHTRA STATE, MUMBAI. Jun 2011
    • Awarded to Sunil Kumar
      GPAT 2011 (AIR 1720) AICTE May 1, 2011
    • Awarded to Sunil Kumar
      1720 Rank in GPAT-2011 AICTE INDIA May 2011
    • Awarded to Sunil Kumar
      48th Rank in National Level Pharma Talent Competition Exam 2008 PHARMA HELPLINE SOCIETY, JAIPUR, RAJSTHAN, INDIA Mar 2008

  • Volunteer Experience

    • Volunteer

      Issued by Social Responsibility Foundation, Vadodara, Gujarat on Aug 2019
      Social Responsibility Foundation, Vadodara, GujaratAssociated with Sunil Kumar