Adish Bhatnagar

GMP Lead Auditor (Freelance) l Director at Accuris Healthcare
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Contact Information
us****@****om
(386) 825-5501
Location
Ahmedabad, Gujarat, India, IN
Languages
  • Hindi -
  • English -
  • Gujarati -
  • Bengali -
  • malwi -

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Experience

    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • GMP Lead Auditor (Freelance) l Director
      • Sep 2020 - Present

      I am a Pharmaceutical professional with a rich experience into Quality assurance area and GMP audits ofsuppliers. I am an independent consultant and a freelance contract GMP Auditor with expertise in performing gap analysis in various functions and performing GMP audits at manufacturing sites of finished formulations, Active Pharmaceutical ingredients (API), Intermediates, Excipients, Packaging Materials in line with required regulatory standards such as Schedule M India, ICH Q7A, EudraLex volume 4 – Part I and Part II, IPEC, ISO 15378, USFDA 21 CFR Part 210 and 211 and PICS.I am expert in conducting supplier audits and performed more than 275 site audits across India, Europe and Asian regions.Accuris is also engaged in drug product filing into Asia, Africa, Latam and CIS regions.

    • Freelance GMP Auditor and Pharmaceutical Consultant
      • Jan 2020 - Sep 2020

      A post graduate (Master of Pharmacy) having experience of conducting more than 250 quality GMP audits of multiple suppliers in my career including API, Excipients, primary/secondary packing materials, sea and air cargo complex for good distribution practices, KSMs, intermediates and contract drug product manufacturing facilities in india, Asia and European continents.If you want assistance on consultancy as Third party contract auditor, Trainer, GMP assistance, response preparation on regulatory and customer audit observations, transition from conventional documentation to software based cost saving implementation and critical document preparation on honorarium basis, It will be my pleasure to serve you.

    • In-charge Quality Compliance
      • Sep 2018 - Jan 2020

      QA compliance

    • Assistant Manager- Corporate Quality Assurance
      • Jan 2011 - Sep 2018

      SAP Managementm, Vendor Audits of raw materials and packaging materials being used for pharmaceutical products.Third party manufacturing and contract manufacturing

    • India
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • T. Pharmacist
      • Feb 2010 - Dec 2010

      IPQA in oral Solid dosage form and Injectable area. IPQA in oral Solid dosage form and Injectable area.

Education

  • KMIPS Rourkela
    Master's degree, Quality Assurance and Pharmaceutical Analysis
    2008 - 2010
  • Devi Ahilya Vishwavidyalaya
    Bachelor of Pharmacy (B.Pharm.), Pharmacy
    2004 - 2008

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