Supervisor, QAIP Manufacturing & Packaging

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 ensuring that quality product is manufactured/packaged and testing of Packaging Components is completed according to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and established Standard Operating Procedures (SOP). This includes responsibility for the daily operation of the QAIP Department and supervision of staff.

Job Responsibilities

 Oversees QAIP Department Daily Operations

• Assign work to Technicians and Document Reviewers.
• Troubleshoot manufacturing/packaging in-process issues and component testing problems; recommend solutions in consultation with Manager.
• Identify non-conformances, provide guidance to Lead Investigators, and initiate/approve investigations as required.
• Perform OOS investigations to determine root cause and corrective actions; notify Manager of all critical or major non-conformances immediately.
• Evaluate physical defects in manufactured/packaged products and packaging components; recommend product disposition.
• Ensure annual inspection batch list for retain samples is completed per SOP.
• Initiate CCRs to revise/create testing bulletins and SOPs; assist in approval of procedures, MPaRs, and PPM Masters; ensure documents comply with compendia and regulatory requirements.
• Ensure new and existing employees are trained on SOPs/GMP and maintain accurate training records.

1. Monitor the work quality & efficiency of the group:
   • Coordinates projects/activities & generates reports in conjunction with Technicians, Document Reviewers & Coordinators as requested by the Manager.
   • Ensures department operates in full compliance with GMP, GLP, SOP, & established safety
   • Ensures department is properly equipped & the equipment is in good working Reviews/approves laboratory test equipment calibration reports.
   • Reviews/optimizes processes & SOPs on a periodic basis to maximize
   • Responsible as Departmental IS Lead for liaising with the IS Business Unit Lead, completing all required IS paperwork & coordinating new employees IS requirements. Monitors group & individual activity via the IP Secure database & addresses as require.

2. Monitor & Reporting:
   • Maintains, approves & schedules attendance & vacations of Ensures adequate department coverage - generate monthly & weekend OT schedule.
   • Schedules & conduct departmental meetings & Departmental
   • Covers Manager’s duties in their
3. For all People Leader (anyone with a direct reports):

Participate & 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 & remove barriers; &, communicate & revisit performance expectations to reinforce & encourage high performance culture & a safe working environment for all employee

• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners & direct leader while continuously improving leadership capabilities by personally seeking feedback & development.
• Create a culture which values trust & provides the opportunity for Employee development & growth in pursuit of our purpose & demonstrating our core Values – Collaboration, Courage, Perseverance & Passion.
• Utilize your networks to attract & hire talent in a comprehensive, differentiated & consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values & commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs & company policies & procedures.
• All other duties as assigned.

Job Requirements

• Education: Bachelor of Science Degree or College Diploma in related field
• Knowledge, Skills and Abilities:
  • Must be familiar with overall pharmaceutical manufacturing and quality systems/process
• Good knowledge of global GMPs and QA/QC systems associated with the manufacture of human drug products
  • Proven ability to lead and motivate subordinates
  • Experience with GMP regulations (e.g. HC, FDA, EU) is an asset
• Must be detail oriented, accurate and Demonstrate personal leadership and accountability. Excellent organization skills and analytical thinking
  • Excellent written and verbal English communication skills
  • Proven ability to effectively problem solves and provides guidance
• Excellent interpersonal skills and ability to work effectively in a team environment within and outside the department
• Ability to manage multiple priorities in a fast-paced Must be able to maintain composure
  • Experience with Microsoft Office (Word, Excel, Access, PowerPoint)
  • Experience with SAP is an asset
• Experience:
  • 3-5 years of QA/QC experience in the pharmaceutical industry

The hiring range for this position is $83,958.00 - $139,930 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience. We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications. The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen, select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.

At Apotex, we are committed to fostering a welcoming and accessible 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.