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, creative 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
In this role, the incumbent will liaise and work directly with the appropriate functional groups within the Apotex group of companies and external raw material manufacturers on technical, quality, and regulatory matters for New Product Development (NPD), Product Life-Cycle Management (PLCM), and Commercial Projects related to active pharmaceutical ingredients (APIs) and excipients. Responsible to provide a high level of expertise with regards to drug master file (DMF) review,
DMF deficiencies, DMF changes, also known as supplier driven changes, raw material out-of-specification (OOS)/out-of-trend (OOT) events resolution between Apotex and its suppliers.
This involves:
Driving the technical aspects of raw material sourcing projects in the region or problem-event resolution by defining, planning, monitoring and reporting project progress/performance against timelines and deliverables.
Updating the Sourcing Hub Leader, Global API Technical Managers and other stakeholders on project progress.
Focusing on the end goals of delivering API technical assessments and problem resolutions with suppliers in the sourcing region.
Job Responsibilities
Ensure that Apotex achieves the most rapid approval on drug product submission dossiers, the incumbent with be the lead reviewer for sourcing region originated DMFs (open-part and closed-part, when available)
Ensure that th
📌 Executive - API Technical (Mumbai)
🏢 Apotex
📍 Mumbai