Senior Quality Assurance Manager
6 days ago
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 nearly 7,200 people in manufacturing, R&D, and commercial operations. Our commitment to vertical integration enables us to develop and sell generic, biosimilar, and specialty products.
Job Summary
As a Senior Quality Assurance Manager, you will be responsible for reviewing analytical data, documents, and calibration reports to ensure compliance with global standards. You will also oversee the development of analytical methods, validate and verify their accuracy, and manage a team to establish operational procedures for smooth product development.
Key Responsibilities
- Review and approve analytical method validation and verification protocols and reports.
- Manage a team to establish and maintain laboratory change controls, deviations, and corrective actions.
- Review and approve laboratory protocols and reports, including stability protocols and summaries.
- Collaborate with the Development Quality Assurance team to support analytical method development and validation activities.
- Ensure compliance with 21 CFR 210 and 211 requirements and other relevant regulatory guidelines.
Requirements
- MPharm or BPharm degree with 10-12 years of experience in Pharmaceutical Quality Assurance.
- Extensive knowledge of GMP and GLP requirements, specifically 21 CFR 210 and 211.
- Experience with oral dosage formulations and R&D quality systems.
- Strong team management and communication skills.
At Apotex, we value diversity and inclusion
We are committed to creating a work environment that is inclusive, accessible, and respectful. If you require accommodation during the recruitment process, please let us know.
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