Janki A patel

Regulatory Affairs Professional with a master's degree in Drug Regulatory Affairs and extensive hands-on experience in analytical method validation and GMP manufacturing support.

Strong

Knowledge of CMC documentation, Module 3 requirements, and analytical data supporting IND, NDA, and NDA submissions.

Quality Control Executive - Torrent Pharmaceuticals Limited, Oncology Division - Gujrat, India

(2021-11 - 2024-05)

• Executed analytical method validation, verification, and transfer to support CMC documentation.
• Generated analytical data for specifications, stability, and method performance.
• Prepared validation protocols, reports, and CMC-relevant documentation for APIs and finish products.
• Supported Cleaning validation and maintained GMP- compliant laboratory records.
• Executed change control and QMS activity using Track Wise to ensure FDA compliance.
• Maintained audit-ready documentation aligned with FDA and ICH guidelines.

Quality Control Apprenticeship - Torrent Pharmaceuticals Limited, Oncology Division - Gujrat, India

(2020-10 - 2021-10)

• Assisted in analytical method validation, Routine Analysis and documentation under GMP condition.

Quality Control Trainee - Cadila Pharmaceuticals Limited - Gujrat, India

• Supported QC activities such as sample testing, documentation, and reagent preparation

Master of Science - Drug Regulatory Affairs - Long Island University, Brooklyn, NY (2025-01 - 2026-12)

Master of Science - Organic Chemistry - Sardar Patel University (2018-06 - 2020-08)