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Team Lead, Validation


This is a Contract position in Brantford, ON posted August 24, 2020.


About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit:


Job Summary

The Team Lead, Validation, leads the analytical method validation activities for products at all lifecycle stages including analytical methods related to cleaning validation with updates to specifications and related forms as required. Works closely with compendial compliance working group to ensure compendial compliance of analytical methods, claiming grade and updating master specification requirements. Participates in new product development and technology transfer activities to ensure timely method validation preceding regulatory submissions and/or deficiency responses when validation is requiredy.

Job Responsibilities

  • Leads analytical Method Validation and external method transfer activitiesResponsible for Analytical Methods/Method Validation section for Annual Product Reviews
  • Oversees comparison studies when methods are changed. Revises or reviews analytical methods, protocols, reports, analytical summaries, SDCs, SOPs. Coordinates testing related to method validation. Ensures physical and chemical testing of any samples is performed according to established requirements listed in test methods.
  • Coordinates reviewing of analytical data for accuracy of test results, completeness and compliance with cGMP, as required.
  • Conducts regular review of post approved products to ensure that all analytical method validation are compliant and meet current validation requirements. Any deficiency in validation is addressed by the team.
  • Validation of any remediated, optimized analytical methods an their implementation on specifications.
  • Liaison between Quality Unit and AR&D in method validation activities, and troubleshooting.  
  • Revises or reviews specification and/or cleaning changes (MSF/Form-13 and/or Form-134) based on cleaning updates or any other project requirements; including detailed description and justification of the changes and initial impact assessments.
  • Under minimal guidance, ensures the quality of all operational aspects of assigned areas, including the review of relevant reports and documentation, the audit/monitoring of Reference Standard systems and/or the coordination of validation, qualification and other quality related activities for assigned areas and/or processes.
  • Involved in audits of method validation systems and conducts appropriate follow-up investigations of issues arising from audit findings to determine root cause and suggest corrective action.
  • Participates in Compendial Compliance Working Group meetings and assesses potential impact, and coordinates implementation of compendial updates for tech transfer and commercial products in relevant documents within Quality Unit.
  • Revises or reviews specifications changes (MSF and/or Form 13) based on compendial updates or any other project requirements; including detailed description and justification of the changes and initial impact assessments.
  • 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 duties as assigned.

Job Requirements

  • Education
    • Minimum B.Sc. in Chemistry or equivalent area of study
  • Knowledge, Skills and Abilities
    • Well acquainted with USP, BP, EP and ICH guidelines and procedures.
    • Must demonstrate an in-depth understanding of test methods/SOPs/compendia and principles of method validation.
    • Sound knowledge with cGMP and ensures work complies with SOPs, cGMP, regulatory requirements and health and safety standards.
    • Proven record of analytical skills and knowledge of using GC, HPLC, UV, IR, DSC, etc.
    • Knowledge of Windows, Microsoft Word, Excel, and Access, instrumentation operating software, or other suitable software.
    • Ability to follow SOPs.
    • Experience
      • Preferably 9-10 years of experience in related field of chemistry or in a Pharmaceutical or equivalent industry


        At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
        Apotex offers 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.