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

The Executive is responsible for execution of LIMS change controls within Apotex Corporate structure.
Maintenance of the Global laboratory documentation and data management systems, including the creation, revision of analytical test methods and In-Process Manufacturing & Packaging CofAs, LIMS CofAs and Test Profiles used in the testing & release of commercial and R&D; products. LIMS static data for R&D; and commercial products,



and the assessment of changes for impact to LIMS static data.
Act as a technical resource and responsible to escalate any critical issues identified during implementation and review of change controls pertaining to LIMS static data changes.

Responsible for product launch readiness and implementation of tech transfer packages for NPD, PLCM, MLCM and site transfersJob Responsibilities

Create, revise and review specifications LIMS documents (CofA, Test Profiles)] and Analytical Test Methods for solid dosage, liquid dosage and raw material products in the corporate document management system in response to ongoing change control activities to support Global product transfers and apply harmonized testing policies for Apotex laboratories.
Perform peer review of documentation and LIMS static data changes for accuracy and compliance with departmental, corporate and regulatory guidelines, and provide feedback as required.
Issue document num

📌 Executive, E-Lab Documentation (Mumbai)
🏢 Apotex
📍 Mumbai