About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com.
Job Summary
Responsible for reviewing of all analytical data generated in ARD-Test Centre in compliance with cGMP and related SOPs and preparing reports for submission to the Regulatory agencies.
Primarily responsible for creating and revising all analytical test methods (chemical and physical) and specifications generated in Analytical R&D; as per current Apotex format and posting the methods on Apoweb. Responsible for the completion of R&D; Change Control Requests (CCRs)



in Trackwise for method creation to transfer of methods to the commercial site. Responsible for support and completion of R&D; CCRs in Trackwise for generation and update of specifications. Also responsible for creating, updating and maintanance of Apotex technical report templates.
This person is seen as a leader and acts as a backup-supervisor for all project updates or queries on submission documents.Job Responsibilities

Requests product codes for current projects from Consultant, Financial data Processes (for SAP product codes) or from Supervisor, NPL-Master Prod&Pkg; Docs (for product acronyms) and assigns recent method numbers for Analytical R&D; and ARPL, as applicable, using Excel database.
Creates and revises analytical test methods generated in Analytical R&D; using current method templates, for example: chromatographic methods, physico-chemical test methods, dissolution test methods.
Assists PD-SD che

📌 Senior Executive (India)
🏢 Apotex
📍 India