Ashwin Shetty

Experience

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  JUBILANT GENERICS LIMITED

  Dec 2021 - Jun 2022

  Project Trainee

  6-month on-site apprenticeship - Responsible for documentation of qualification activities performed for GAMP-4 systems under direct supervision of the project leads- Ensured compliance of documents with USFDA guidelines- Worked with cross functional teams to facilitate and expedite the approvals of qualification protocols- Completed several industry-curated training modules based on process validation workflow, SOP creation and data integrity- Trained in the development of qualification protocols and SOPs for the validation of pharmaceutical manufacturing equipment by the concerned Subject Matter Experts- Liaised with cross-functional teams to expedite the approval of the validation process of data logger systems- Coordinated with multiple stakeholders, both internal and external. Show less

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  Himalaya Wellness Company

  Jul 2023 - now

  International Regulatory Affairs Associate