Job Summary

This role is responsible for supporting the Quality Systems required to ensure that Apotex and Apotex's Affiliates meets its regulatory and GMP compliance obligations for products supplied by Third Party Organizations (TPOs). They must develop strong working relationships and collaborate with both internal and external stake holders to resolve quality related matters, and perform follow-ups, reviews and approvals of documentations as they relate to third party products.

Job Responsibilities

• Review and/or approve the following documents relating to third party products:
• Participate as quality representative in cross-functional teams in support of analytical method transfer/verification for third party products.
• Review and/or approve internal deviation investigations and ensure proper root cause identification, impact assessment and CAPAs, as well as accuracy, completeness, timely initiation and completion of investigations in a compliant manner.
• Provides on-going support on the Quality Systems to monitor key quality metrics to enable evaluation of trends and continuous assessment of compliance risks.
• Lead update in Quality Agreements with TPOs. Makes decisions in consultation with the Manager, External Quality on the respective quality responsibilities to ensure both parties are compliant to GMP.
• Provides support to Manager, External Manufacturing Quality, in reviewing GMP Quality Documents that form part of Product Compliance Files (PCF) for third party products.
• Provides support to Manager, External Quality Operations, in processing customer requests as they relate to products supplied by TPOs.
• Perform disposition of semi-finished and finished batches supplied by TPOs as needed and upon completion of all required training and qualification. This includes verifying that required manufacturing, packaging and testing documents are complete and then executing the required SAP transactions to ensure that all batch disposition activities comply with SOPs and regulatory requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor's degree in sciences or related field and at least three years of experience in the pharmaceutical industry OR a combination of a college diploma in pharmaceutical technology or related field and at least six (6) years of experience in the pharmaceutical industry, 5 years in a QA or QC role.
• 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.
• Experience
  • Experience with domestic/international regulations (e.g. HC, FDA, EU) is an asset.
  • Must be detail oriented, accurate and reliable. Demonstrate personal leadership and accountability. Excellent organization skills and analytical thinking.
  • Excellent written and verbal English communication skills.
  • Excellent interpersonal skills and ability to relate well to internal and external customers.

The hiring range for this position is $83,958- $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.