R&D QA Liquid Dose Manager

4 weeks ago

Richmond Hill, Ontario, Canada APOTEX Full time

About Apotex Inc.

Apotex Inc. is a global health company that produces high-quality, affordable medicines for patients worldwide. With a presence in over 75 countries, Apotex employs almost 7,200 people in manufacturing, R&D, and commercial operations.

Job Summary

The Manager, R&D QA Liquid Dose is responsible for leading a team that supports the compliance and business needs of R&D manufacturing, packaging, and laboratory operations in Richmond Hill. Key responsibilities include:

  • Managing QA activities to ensure GMP compliance and business needs are met.
  • Collaborating with R&D manufacturing, packaging, and laboratory teams to determine scheduled activities and changes to the manufacturing schedule.
  • Overseeing the review and approval of R&D manufacturing and packaging documents, as well as R&D specifications, test results, and release of experimental raw materials.
  • Providing leadership and operational oversight for the establishment of records and processes in support of 21 CFR Part 4 requirements for Combination Products.
  • Reviewing and approving Master Manufacturing/Packaging Masters and executed batch records for non-commercial materials.
  • Overseeing the audit of data to release R&D raw materials, IMPs, and registration/submission batches.
  • Reviewing and approving Pharmaceutical Development Reports, analytical method validation protocols, and reports for R&D methods and other documents required for regulatory applications/submissions.
  • Reviewing, coordinating, and approving activities for deviation investigations and CAPA for experimental materials and manufacturing of non-commercial batches.
  • Supporting change through review and approval of change control requests for master manufacturing/packaging documents, analytical methods, specifications, SAP material code creations, SAP Master Data, Standard Operating Procedures, and other controlled documents.
  • Ensuring the implementation of appropriate processes and continuous improvement initiatives to maintain effective quality standards in R&D.
  • Providing assistance and leadership in preparation activities leading up to, during, and following regulatory or customer inspections.
  • Managing the R&D self-inspection program at Richmond Hill.
  • Serving as the primary contact and consultant for quality issues pertaining to R&D operations.
  • Conducting resource planning analysis for headcount forecast in conjunction with the Associate Director, CMC QA.
  • Participating in and leading performance conversations with employees, checking on their progress toward achieving objectives, offering support, and removing barriers.
  • Creating a culture that values trust and provides opportunities for employee development and growth.
  • Collaborating with the Associate Director, CMC QA, to develop programs for ensuring the continuous improvement of quality operations in Product Development.

Requirements

To be successful in this role, you will need:

  • A B.Sc. in Chemistry, Microbiology, or a related science.
  • A thorough understanding of GMP requirements and their application in a manufacturing and packaging environment within R&D.
  • Strong knowledge of regulatory requirements for IMPs and registration batches.
  • Excellent interpersonal skills and recognized leadership ability.
  • Demonstrated ability to handle multiple work assignments.
  • Experience with technical report writing/scientific documentation.
  • Minimum six (6) years of QA experience in the pharmaceutical industry, three (3) years of supervisory experience, preferably in a QA role.

About Apotex

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.

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