Prajwal Dake

junior Regulatory affairs specialist

Role
Process Associate (Regulatory Affairs) at Tata Consultancy Services
Location
Pune Division, MH, IN
LinkedIn followers
500 followers

About Prajwal Dake

Evaluation of specification, Residual solvent statement and Certificate of analysis for RS assessment. • work on EU region to update specifications for the Type I & Type II variations. • Having knowledge of Q3C guideline and PDE calculation. • Support on project Stability for report authoring and verification. • Create, revise and/or obsolete specifications for global packaging development using TRU. • Create and manage global change control (GCC) for specifications. • Evaluation of artwork for dose and MDD evaluation. • Worked on citrix (ELN) and global formula app under Global residual solvent assessment project. • Having knowledge of IPEC Nitrosamine impurities risk evaluation. • Work on packaging related tasks such as bill of materials, artwork review, purchase orders, raw material codes. • Coordinate with various internal departments, suppliers and distributors to collate required information/documentation governing the changes, as applicable. • Managing day to day operations and delivery for the projects. • Implement use of consistent, efficient, and quality process to meet timelines and deliverables. • Assist in preparation of work instructions/ standard operating procedures.

Experience

  1. Process Associate (Regulatory Affairs)

    Tata Consultancy Services

    Jun 2025 — Present

Education

  • Shivaji University

    Bachelor of Pharmacy - BPharm

    2016 — 2020

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Prajwal Dake — Process Associate (Regulatory Affairs) at Tata Consultancy Services in Pune Division, MH, IN | Unifers