Assistant Manager, QualAssr-ARPL-AQAQ AR

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 .

Job Summary

Responsible for effective review and approval of Change controls / Laboratory investigation reports / Deviations / Lab events / Corrective action and preventive action (CAPA's).

Job Responsibilities

• Review and approval of lab investigation reports (LIR), Deviations, Questionable results, Out of specification (OOS) and Out of trend (OOT) investigations.
• Preparation and review of Standard operating procedures.
• Review and approval of lab events and Temporary changes.
• To review laboratory data with respect to investigations.
• Co-ordinating with cross functional team for the closure of investigations in timely manner.
• Responsible for review and approval in various stages of change controls like QA Acceptance, Change control assessment, QA summary, M-Doc approvals, action item verification & Final closure.
• Co-ordination with regulatory department for regulatory submisssions / Post approval changes.
• Review and approval of CAPA.
• Review of LIR trend reports.
• Responsible for approval of Specification / Certificate of analysis and method of analysis.
• Support to regulatory and customer audits.
• Identify system improvement opportunities for process efficiency.
• Work both independent & as a part of intra / inter departmental teams to ensure that all work is completed in a timely manner to meet compliance.
• Ensure to respond immediately on queries from cross functional teams.
• Approval of reports wherever applicable.
• Work as a member of a team to achieve all outcomes.
• 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.
• All other relevant duties as assigned.

Job Requirements

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.

Skills Required

Change Control, Capa