Associate, MTS - Cleaning Validation

at  Apotex

About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.
Job Summary
Responsible for planning and executing cleaning validation activities in accordance with FDA, HPFBI, EMA, and ICH’s guidelines and applicable Apotex policies and processes.
Job Responsibilities
Liaises with key business members to generate CV Product and Equipment Risk Assessment reports, when evaluating new and/or changes to product formulations and manufacturing equipment to assess if Cleaning Validation Protocol studies are required.
Generates Cleaning Validation protocols/studies, and subsequent reports. In developing these studies, sampling requirements and acceptance criteria are selected to represent worst-case conditions and the sampling and testing criteria are designed for world-wide regulatory compliance (FDA, HPFBI, EC and ICH standards).
Co-ordinates the cleaning validation event activities (sampling, cleaning, testing requests) with the assistance of production/packaging as required.

Please refer the Job description for details