Tushar Patel

Director of Quality@Fremed Pharmaceutical JSC
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Summary

Director of Quality | MS in Pharmacy | Quality Compliance | Risk Management | Certified Lead Auditor. Versatile Pharmaceutical Quality Head, bringing thought-provoking perspectives in setting-up & maintaining Quality Pharmaceutical Manufacturing Standards, Pharmaceutical Quality Systems (PQS), GDP, APQR, Self-Inspection, Audits, Trainings, Quality Reviews, Technology Transfer, Stability Study and Method Validation across state-of-the –art Manufacturing Plants. Through-out my career, I have successfully led Injection & OSD Plants from Inception, Commissioning, Qualification / Validation (C&QV) to Release of High-Quality Pharmaceutical Products in various Dosage Forms (Solid, Liquid Orals and Injectable) Commercially driven dynamic go-getter, with expertise in Technology Transfer from R&D - lab to pilot scale production, commercialization and launch of high-quality products, gain customer satisfaction, business and revenue growth. Led Quality Audits of Raw & Packaging Materials/ Finished Products, CMO, Supplier and CFA Facilities, achieving nil non-compliance, positioning the company as a trusted Pharma Brand in the wider global community. Oversaw Data Integrity Lifecycle Management, ensured that CMO Site has an effective Data Integrity Program, and led DI Assessment Recognized by seniors as a Focused Leader & Problem-Solver and by Colleagues & Friends as Collaborative and Trustworthy always willing to help people. Pleasing personality with a zest for life, in my free time I like reading articles on pharmaceuticals guidelines and cooking food. I strongly believe in the values of Integrity, Honesty, Discipline, with a strong commitment to organisational goals. Known for shaping abstract ideas into realistic plans, work with limited resources, manage challenging tasks and deliver exemplary results. I have led and mentored teams with an equal desire to win

Work experience

  • Director of Quality

    Fremed Pharmaceutical JSC
    2024.04-Current(2 years)
  • GM Quality Assurance

    SHILPA MEDICARE LTD
    2021.07-2024.03(3 years)
  • DGM Quality Assurance (Site Quality Head)

    RV Lifesciences Ltd. (Formally known as Atra Pharmaceuticals Ltd)
    2020.02-2021.07(a year)
  • Site QA Head

    Wockhardt Ltd.
    2016.02-2020.01(4 years)
  • Sr. Manager (Site QA Head)

    Fresenius Kabi Oncology Ltd
    2015.01-2016.01(a year)
  • Sr. Manager - Quality Assurance (Site QA Head

    Akorn Indai Pvt Ltd
    2011.11-2015.01(3 years)
  • Executive QA

    Piramal Healthcare Ltd. ( Now ABBOTT)
    2006.01-2008.01(2 years)

Educational experience

  • Birla Institute of Technology and Science, Pilani

    Master of Science - MS, Pharmacy, Pharmaceutical Sciences, and Administration
    2021.01-2022.01(a year)
  • SES'S R.C.PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR, DIST DHULE

    Bachelor's degree, B. Pharmacy
    1993.01-1998.01(5 years)
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