Project Leader, External R&D Quality
11 hours ago
www.apotex.com. 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.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
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