Job Description
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, 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
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 regulatory affairs activities.
- Batch release in SAP for Raw material, Solvents, Operational supplies (Packaging Materials, Filter bags etc..).
- Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
- Utilize open, honest, two way communication to build trust-based relationships with employees, business partners .and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
- Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
- Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
- Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
- To adhere the EHS policy and procedure in routine activities
- To involving EHS related activities on need basis
- All other duties as assigned
Responsabilités inhérentes à l’emploi
Job Requirements
- Experience
- 10 to 12 year experience, with demonstrated skill in preparation of protocol and reports, monitoring of process validation, etc.
At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
