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, cutting-edge 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 processing and managing changes required to Master Production and Packaging documentation; maintaining the Document management and SOD system for Apotex.
Job Responsibilities
- Provide coaching, assistance and ongoing support to Change Owners on requirements for completing Change Control packages.
- Responsible for creating and/or making formatting changes and edits to draft master documents.
- Serve as a technical resource in the development of Master Production & Packaging documentation by advising on current Document Naming Conventions, Active Standard Instruction requirements & Master Template issues.
- Conduct Detailed Impact Analysis for Master Production Documents according to proposed change details.
- Perform functions related posting and publishing approved documents.
- Responsible for initiating change control packages in the change management system with detailed change(s) descriptions and the corresponding rationale(s) for Manufacturing, Packaging, POMSNET recipes, SODs and supporting SAP information.
- Review the accuracy of all manufacturing instructions imported into master documents during detailed Impact Analysis as listed in the scope of the change request.
- Track and follow up the progress of change control requests to meet committed business timelines.
- Using the LEAN tools and methodology, work as a change agent t
📌 Lead Executive (Mumbai)
🏢 Apotex
📍 Mumbai