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 leading Supplier Driven changes (SDC) Projects At ARPL, New Supplier Qualification (NSQ) Projects for NPD (New Product Development)/Product Life Cycle Management (PLCM) related to active pharmaceutical ingredients (APIs) and excipients. Also work directly with the appropriate functional groups within Apotex, external manufacturers, including Apotex Pharmacies Group companies, on SDC (commercial and new product development)
and new source qualification related to active pharmaceutical ingredients (APIs) and excipients.
Job Responsibilities
• Initiate Change Controls in QMS Track Wise for Supplier Driven changes impacting Recent Product Launch and commercial APIs.
• Lead cross-functional Global API Projects Changes and initiatives, serving as the project lead and primary contact for assigned projects at Apotex, throughout the development of project plans to successful project completion within the required timelines
• Demonstrate technical expertise to explain the API related issues to any technical, quality or regulatory teams and drive the discussion in conclusive manner.
• Make sound technical decisions based on review of internal/external complex technical reports, interpret the data/issues, participate in complex API related investigations and support deficiency responses related to regulatory submission.
• Facilitate and drive the
📌 Sr Executive II, Project Mgmt R&D-ARPL-PMRD AR (India)
🏢 Apotex
📍 India
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