Quality Assurance Manager
4 days ago
We are seeking a highly skilled Quality Assurance Manager to join our R&D team at Apotex. The successful candidate will be responsible for ensuring the quality and compliance of our manufacturing and packaging operations.
Key Responsibilities- Develop and maintain a focused team to support compliance and business needs of R&D manufacturing, packaging, and laboratory operations.
- Review and approve experimental batch manufacturing documents, supervise and train staff, and prepare and respond to audits.
- Ensure investigation and deviations are handled in a compliant manner with pre-defined timelines.
- Work with the Associate Director, CMC QA to develop programs for ensuring the continuous improvement in the quality of operations in Product Development.
- Manage on-going QA activities which support the business and GMP compliance needs of manufacturing, packaging, and laboratory operations.
- Interact with Richmond Hill R&D manufacturing/packaging groups, laboratories, and Global R&D Project Management (GPM) to determine scheduled activities and changes to the manufacturing schedule.
- Bachelor's degree in Chemistry, Microbiology, or related science.
- Minimum six (6) years of QA experience in the pharmaceutical industry, three (3) years of supervisory experience, preferably in a QA role.
- Thorough understanding of GMP requirements and their application in a manufacturing and packaging environment within R&D.
- Strong understanding of regulatory requirements for IMPs and registration batches.
- Excellent interpersonal skills with recognized leadership ability.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected, and supported.
We offer accommodation for applicants with disabilities as part of our 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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