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
Responsible for ensuring the Analytical data review Review & Approval of Lab events OOS,OOT
Job Responsibilities
- Responsible to monitor the Analytical data review performed by review team.
- Responsible to monitor the investigations performed by QC investigation team.
- Review & Approval of Lab events, Out of specification results (LIRs), Out of trend (OOTs), Deviations, Anomalous results Investigation reports.
- Coordination with cross functional departments for smooth functioning of analytical activities.
- Review and approval of deviations in Track wise.
- Review and approval of Certificate of analysis (COAs).
- Review and approval of Specifications in LIMS and approvals of SOPs and STPs.
- Monitoring of stability studies activities, Review and approval of shelf life certificates & Protocols.
- Approval of protocols & reports of analytical method validations, verifications, Transfers and risk assessment reports.
- Approval of certificate of analysis of reference standards & Impurity standards.
- Preparation/Approval of SOPs and forms related to analytical activities.
- To perform Change control impact assessments and approvals in Trask wise.
- To perform un-announced Realtime checks and Internal audits as per the Schedule.
- Managing of Customer Request Samples activities.
- Coordination and providing the support for Business development and regul