About Apotex Inc.
Apotex Inc. is a Canadian-based global health company committed to producing high-quality, affordable medicines for patients around the world. Employing nearly 7,200 people globally, Apotex operates across manufacturing, research and development (R&D), and commercial sectors. Apotex medicines are accessible in over 75 countries, focusing on generic, biosimilar, and specialty pharmaceutical products. For more information, visit www.apotex.com.
Job Title: Project Leader, R&D QA Third Party
Job Summary:
The Project Leader, R&D QA Third Party oversees the quality disposition of non-commercial finished products (including small molecules and biopharmaceuticals) manufactured by third-party partners for Apotex. Acting as a technical expert, this role ensures regulatory compliance through meticulous review of master documentation, method validation, change controls, and manufacturing/packaging documentation for R&D clinical, submission, or stability batches. Additionally, this individual supports the establishment of R&D Quality Agreements with third-party partners as needed.
Key Responsibilities:
Quality Assurance & Batch Release:
Serve as the primary R&D QA contact for product quality issues related to non-commercial batches manufactured by third-party partners.
Perform final batch disposition/release for clinical studies or reject batches where applicable.
Review and approve manufacturing, packaging, and analytical documents to ensure accuracy and completeness before batch release.
Trend and analyze investigations to identify and address quality-related issues.
Documentation & Compliance:
Review and approve master documents, laboratory protocols/reports, stability protocols, and associated change controls from third-party partners.
Ensure all investigations, deviations, and corrective actions are resolved and documented appropriately.
Oversee method validation and technology transfer protocols and reports.
Regulatory & Partner Support:
Support external partners during regulatory inspections and assist in resolving any quality concerns arising from these inspections.
Participate in the auditing of external partners to ensure Good Manufacturing Practices (GMP) compliance.
Facilitate the transition from R&D Quality to Commercial Quality as needed.
Collaboration & Teamwork:
Work with cross-functional teams to ensure timely and high-quality regulatory submissions.
Support the establishment and maintenance of R&D Quality Agreements with third-party partners.
Other Responsibilities:
Adhere to Apotex's compliance programs, Global Business Ethics, Safety and Environment policies, and HR policies.
Collaborate as a team member to achieve organizational outcomes.
Perform other duties as assigned.
Job Requirements:
Education:
Bachelor of Science (B.Sc.) in Chemistry, Biochemistry, or a related scientific discipline.
Experience:
Minimum of 6 years of experience in the pharmaceutical industry.
Knowledge, Skills, and Abilities:
In-depth understanding of GMP regulations.
Familiarity with the new product development process for pharmaceuticals and biopharmaceuticals is an asset.
Strong verbal and written communication skills.
Exceptional organizational skills and the ability to work independently and collaboratively.
Why Join Apotex?
Inclusive Work Environment: A commitment to fostering a workplace where all employees feel valued and supported.
Opportunities for Growth: Work on innovative pharmaceutical projects and contribute to global health initiatives.
Supportive Policies: Apotex offers accommodations during the recruitment process for applicants with disabilities.
Take the next step in your career and make an impact on the pharmaceutical industry with Apotex. Apply today!
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