Project Leader, External R&D Quality

Job Summary

The Project Leader, R&D QA Third Party is responsible for the disposition activities of non-commercial finished products (for small molecules and biopharmaceuticals) manufactured by third party partners for Apotex. The incumbent acts as a technical resource and reviews master documentation, analytical method validation, change control, manufacturing/packaging documentation, test results and investigations for R&D clinical, submission or stability batches. This person also provides support for coordinating activities for establishing R&D Quality Agreements where required with third party partners.

Job Responsibilities

• Act as the primary R&D QA contact for all product quality issues for non-commercial batches manufactured by third party partners.
• Review and approve master documentation, laboratory testing/protocols/reports, stability protocols and associated change controls from third party partners for non-commercial batches.
• Conduct impact analysis of the proposed corrective & preventative actions by engaging Apotex subject matter experts, as required.
• Review and approve method validation and technology transfer protocols and reports.
• Establish and maintain a system to trend investigations and create visibility of quality related issues for third party partners.
• Ensure that all manufacturing, packaging and analytical documents pertaining to the batch are complete, accurate and reviewed and all investigations/deviations have been closed prior to release.
• Performs final disposition/release of batches for clinical studies or rejects batches where required.
• Provide support to external partners to stay abreast of regulatory inspections at their sites and assists in resolution of quality concerns arising from those inspections.
• Assist with auditing of external partners to ensure GMP compliance.
• Act as the R&D point of contact for the transition from R&D Quality to Commercial Quality.
• Work in a cross functional team to ensure the delivery of quality submissions.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Sc in Chemistry, Biochemistry or a related science.
• Knowledge, Skills and Abilities
  • Thorough knowledge of GMPs required.
  • Knowledge of new product development process of pharmaceuticals and biopharmaceuticals an asset.
  • Excellent verbal and written communication and organizational skills.
  • Ability to effectively work both independently and in a team environment.
• Experience
  • Minimum of 6 years of experience in the pharmaceutical industry.