Deputy Manager External R&D

The Project Leader External 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.

• 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.

• Education
  • in Chemistry Biochemistry or a related science.
• Knowledge Skills and Abilities
  • Thorough knowledge of GMPs required.
  • Knowledge of new product development process and of pharmaceuticals and biopharmaceuticals is 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.