16 Aug
|
Apotex
|
Bengaluru
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
- Management of review of Analytical method validations, Analytical Method Transfers, Analytical method verifications, cleaning method validations, Laboratory personnel qualifications, Lab Instrument Qualifications/calibrations and working standard qualification protocols and reports, along with handling of quality management system at AR&D; and Analytical Test Centre (ATC) laboratories at ARPL.
- Management of review of Master Formulation Records,
Batch manufacturing records, Batch packaging records, Trial batch documents, Instrument Qualifications/calibrations records at FR&D.;
Job Responsibilities
- Review of Analytical method development data, Analytical method validations, Analytical Method Transfers, Laboratory personnel qualifications, Analytical method verifications, Method life cycle management (MLCM), cleaning method validation protocols and reports, along with review of Management of review of Master Formulation Records, Batch manufacturing records, Batch packaging records, Trial batch documents, Instrument Qualifications/calibrations records.
- Facilitation for timely initiation and closure of Change controls through Trackwise.
- Ensure for the review and completion of the change assessments in QMS Trackwise Change control system.
- Accountable for the review of calibration and Qualification reports for Analytical laboratory instruments.
- Rev
📌 Executive - Quality Assurance (Bengaluru)
🏢 Apotex
📍 Bengaluru