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
The Project Leader, External R&D; QA Third Party is responsible for the disposition activities of non-commercial finished products (for small molecules and biopharmaceuticals) manufactured by third party partners for Apotex. The incumbent acts as a technical resource and reviews master documentation, analytical method validation, change control, manufacturing/packaging documentation, test results and
investigations for R&D; clinical, submission or stability batches.



This person also provides support for
coordinating activities for establishing R&D; Quality Agreements where required with third party partners.Job Responsibilities

Act as the primary R&D; QA contact for all product quality issues for non-commercial batches manufactured by third party partners.
Review and approve master documentation, laboratory testing/protocols/reports, stability protocols and associated change controls from third party partners for non-commercial batches.
Conduct impact analysis of the proposed corrective & preventative actions by engaging Apotex subject matter experts, as required.
Review and approve method validation and technology transfer protocols and reports.
Establish and maintain a system to trend investigations and create visibility of quality related issues for third party partners.
Ensure that all manufacturing, packaging and analytical documents pertaining to the bat

📌 Deputy Manager (Karnataka)
🏢 Apotex
📍 Karnataka