R&d QA Operations Associate - Contract

September 24 2020
Categories Operations (manufacturing, packaging), Pharma, Biotech, Sciences, R&D, Production, Operations, Quality, Safety, Production, Operations, Quality, Safety, Research and development, Transport, Logistics, Supply Chain, Purchasing
Etobicoke, ON

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 Associate, R&D QA Operations RD8 is responsible for monitoring the quality of operational aspects related to Formulations Development and R&D Technical Operations processes at the GTA Solid Dose sites. The associate provides approval for the master production documents and investigation records. Furthermore, this role is expected to provide leadership and mentoring to junior associates.

Job Responsibilities
  1. Review and approve master production documents for manufacturing and packaging of R&D products.
  2. Audit and approve executed batch records for Submission, Stability, Demonstration and Bio-Clinical batches.
  3. Review, coordinate and approve activities for investigations and SAP F notifications for the manufacturing of non–commercial batches.
  4. Assist in the preparation activities leading up to Regulatory or customer inspections
  5. Review protocols and reports such as equipment validation protocols and technology transfer protocols.
  6. Represent R&D QA during inter/intra departmental meetings as required.
  7. Assist in training and mentoring junior members of the team.
  8. Acts as delegate for Supervisor as required.
  9. Review and approve R&D change control requests.
  10. Works as a member of a team to achieve all outcomes.
  11. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence.
  12. Performs all work in accordance with all established regulatory and compliance and safety requirements.
  13. All other duties as assigned.
Job Requirements
  • B.Sc. in Chemistry or Biochemistry or in a related science
  • Minimum of 5 years of experience in the pharmaceutical industry, 2 years in Quality Assurance
  • Knowledge of GMP and cGMPs requirements
  • Experience with solid dose manufacturing techniques an asset
  • Knowledge of Microsoft Office programs and laboratory LIMS systems an asset
  • Ability to effectively work both independently and in a team environment
  • Superior time management and organizational skills
  • Experience with technical report writing and scientific documents an asset
  • Clear and concise written and oral English communication skills

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.

Apply now!

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