Jobs in Whitby, Canadá

Our client a, patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases seeking a QA Person In plant to join their growing team.

Responsibilities :

• Perform batch record review of investigational products manufactured at CMO partners.
• Perform QA / client review for internal and / or CMO Quality System records, manufacturing documents, analytical methods, and qualification / validation documentation.
• On-site oversight of CMO operations as needed.
• Ensure all necessary documents / forms / records are authorized to facilitate movement of cell product to clinical sites
• Support Manufacturing to collect and monitor key performance indicators of CMO and contract / external laboratories.
• Review, maintain, and execute against Quality Agreements with the Supplier / CMO network.
• Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met as required.

Skills :

• 8+ years of pharmaceutical manufacturing and / or Quality Assurance experience, with at least 2 years' experience in the field of cell therapies preferred.
• Expertise with cGMP manufacturing as well as global regulatory regulations and requirements for biopharmaceutical products and ATMPs
• Ability to operate in a Controlled / Classified Environment, including ability to successfully maintain aseptic technique and complete cleanroom gowning qualification requirements.
• Demonstrated ability to manage multiple complex relationships within a CMO network
• Experience with electronic Quality Management Systems
• Experience in conducting or hosting Quality and / or Health Authority audits.

Education :

• Degree (Bachelors or higher) or equivalent experience in life sciences, Biology, Biochemistry, Chemical Engineering, Biotechnology