Project Leader, External R&D QA

Date: Sep 20, 2022

Location: North York, ON, CA, M9L 1T9

Company: Apotex

 

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: www.apotex.com.

Job Summary

The Project Leader, R&D QA Third Party is responsible for the disposition activities of non-commercial finished products (for small molecules and biopharmaceuticals) manufactured by third party partners for Apotex. The incumbent acts as a technical resource and reviews master documentation, analytical method validation, change control, manufacturing/packaging documentation, test results and investigations for R&D clinical, submission or stability batches. This person also provides support for coordinating activities for establishing R&D Quality Agreements where required with third party partners.

Job Responsibilities

  • Act as the primary R&D QA contact for all product quality issues for non-commercial batches manufactured by third party partners.
  • Review and approve master documentation, laboratory testing/protocols/reports, stability protocols and associated change controls from third party partners for non-commercial batches.
  • Conduct impact analysis of the proposed corrective & preventative actions by engaging Apotex subject matter experts, as required.
  • Review and approve method validation and technology transfer protocols and reports.
  • Establish and maintain a system to trend investigations and create visibility of quality related issues for third party partners.
  • Ensure that all manufacturing, packaging and analytical documents pertaining to the batch are complete, accurate and reviewed and all investigations/deviations have been closed prior to release.
  • Performs final disposition/release of batches for clinical studies or rejects batches where required.
  • Provide support to external partners to stay abreast of regulatory inspections at their sites and assists in resolution of quality concerns arising from those inspections.
  • Assist with auditing of external partners to ensure GMP compliance.
  • Act as the R&D point of contact for the transition from R&D Quality to Commercial Quality.
  • Work in a cross functional team to ensure the delivery of quality submissions.
  • 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
    • Sc in Chemistry, Biochemistry or a related science.
  • Knowledge, Skills and Abilities
    • Thorough knowledge of GMPs required.
    • Knowledge of new product development process of pharmaceuticals and biopharmaceuticals an asset.
    • Excellent verbal and written communication and organizational skills.
    • Ability to effectively work both independently and in a team environment.
  • Experience
    • Minimum of 6 years of experience in the pharmaceutical 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.