About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, creative 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
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