Amal Mehta

About Amal Mehta

A highly energetic Quality Expert with a vast experience in managing and conducting…

Experience

1. Qa Stability Program Associate - Aqpic

   SteriMax Inc.

   Nov 2021 — Present · Oakville, ON, CA

   Develop and review protocols, reports and other stability documents.§ Perform stability impact assessments pertaining various change controls and complete associated tasks. § Perform activities required to support and maintain the internal and external stability program. § Generate and maintain stability-related documents in compliance with applicable SOPs. § Perform stability sample pulls as per schedule and submit them to the QC lab for testing. § Maintain stability inventory and coordinate testing of stability samples and keep track of any associated CoAs/reports. § Review contract manufacturer’s stability documents in a timely manner for compliance with internal specifications and SOPs, OOS/borderline results, significant trends. § Record completion of stability activities to facilitate reporting of metric results for management review.§ Perform any activities required to execute and document external testing at contract labs.§ Support lab and non-conformance investigation as required. § Perform trend analysis and prepare APQR memos for the Quality Compliance team with up-to-date stability data. § Reviewed >500 CMO reports between Dec 2021 and Apr 2022 to help clear back log. § Noted discrepancies during stability data review which has led to approximately 30 specifications being revised. § Drafted approximately 90 specifications in order to assist with closing deviations and change controls.

Education

• University of Toronto

  Chemical Engineering

  2006 — 2010

• Seneca College

  Post Grad Certificate

  2017 — 2018