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, 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
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 (India)
🏢 Apotex
📍 India