Janhvi Vasant Nanda

Experience

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  EVERSHINE DRUG PRODUCT PRIVATE LIMITED

  May 2017 - Jun 2017

  Intern

  Assisting in the Quality Check and Research Department, I received training in using instruments such as the Polarimeter, High-Performance Liquid Chromatography, and Ultraviolet Spectrometer. I also practiced Good Lab Practices and completed Stability Testing Methods. Additionally, implemented process control, validation, deviations, change control, standard operating procedures, good housekeeping practices, and good documentation practices.

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  BIDWAI CHEMICALS PRIVATE LIMITED

  May 2018 - Jun 2018

  Intern

  I was assigned to a department where I comprehended Good Documentation Practices, Validation, Process Control, Stand Operating Procedures, Deviations, Change Control, Good Housekeeping Practices, and Stability Testing.

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  FDC Limited

  May 2019 - Jun 2019

  Quality Assurance and Quality Check Intern

  Positioned in the Analytical Methods Development Laboratory in the Research and Development Centre wherein ensured experimental and testing work was carried out following the approved study protocols. Participated in process improvement, development, and qualification efforts; conducted laboratory-based research as specified in protocols; analyzed and interpreted results and examined bulk pharmaceutical materials, intermediates, drug products, drug formulations, contaminants, and degradation products. Show less

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  Cognizant

  Jan 2021 - Dec 2021

  Junior Data Analyst

  As a case processor, I assessed case data from several source documents and correctly classified adverse events using the nomenclature of MedDRA. In addition, drugs were coded using the WHO Drug Dictionary, medical plausibility was confirmed, causality was assessed, case narratives were created in compliance with the medical judgment, and the deadlines and procedures for submitting Individual Case Safety Reports were confirmed.

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  Northeastern University

  May 2022 - Aug 2022

  Instructional Assistant
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  Vertex Pharmaceuticals

  Apr 2023 - Jun 2023

  Regulatory Affairs CMC Intern

  Performed IMPD revisions with a focus on the "Module 3: Quality" section of the Veeva Vault RIM database and staged the CTD sections of an IND. Worked on the MHRA, the FDA Health Authority Questions, and stability reports. In addition, checked the CMC questions for repetition and made the appropriate changes. Provided the Reg CMC team with submissions and helped oversee the management of the activities and regulatory impact assessments brought about by change controls.

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  VIA Global Health

  Sept 2023 - Dec 2023

  Regulatory Affairs Intern

  Efficiently used the GxP guidelines and provided thorough documentation on the regulatory certification requirements for all classes of medical devices in North African nations such as Sudan and South Sudan, as defined by the country of interest and mapped back to the CE-specified class.

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  Biolyst Scientific

  Mar 2024 - now

  Regulatory Affairs Quality Assurance Associate