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Project Leader, External R&D Quality

6+ years
Not Disclosed
10 Dec. 12, 2024
Job Description
Job Type: Full Time Education: Bsc/Msc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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!