Supplier Quality Specialist

The supplier quality specialist maintains the site's Supplier Quality Management (SQM) program in accordance with applicable cGMP. The supplier quality specialist performs the quality related tasks in the approval, certification and exit of materials, services and the related suppliers and performs the final SQM approval. He establishes and maintains technical quality agreements with suppliers. In addition, he manages the Supplier Quality Review Board, ensures the quality oversight of active suppliers, and updates the SQM status. Finally, he creates and maintains the supplier files and documentation.

Responsabilities :

• Supports the operations and activities required for the approval of new suppliers and ensures they meet the quality and regulatory requirements (GMP certification, BSE/TSE, elemental impurities, residual solvents, etc.). Ensures that the materials identified for certification meet all the regulatory and quality requirements before they are authorized for reduced testing;
• Ensures the quality monitoring of active suppliers and updates the SQM status accordingly. Performs the Supplier Quality Risk Assessment (SQRA) of active suppliers and updates it when new information is available. Participates or initiates supplier issue investigations when required, follows up on the completion of these investigations and ensures appropriate actions are taken. Reviews regulatory inspections and supplier audit outcomes of active suppliers;
• Negotiates and maintains Technical Quality Agreements (TQA) and Change Notification Agreements (CNA) with required suppliers. Creates and updates TQA and CNA templates in collaboration with the legal team and relevant internal business units. Reviews TQAs for appropriateness at the required intervals;
• Manages the Supplier Quality Review Board (SQRB) agenda, documents the SQRB decisions and required actions. Requests and stores the appropriate supplier documentation. Maintains the supplier files;
• Supports the other compliance team activities (risk management program, APQR, walkthroughs, Internal/external audit, etc.). Helps to develop tools to help monitor or improve the site compliance. Reviews and performs the quality assurance approval of specific documents (ex.: Stability protocols or reports, MPTP, Control Strategy, QRM, digital proofs of boxes and labels, etc.).

Knowledge & skills :

• Bachelor in science;
• 4 to 7 years in the pharmaceutical industry with quality experience;
• Demonstrated experience with regulatory agencies including Health Canada, FDA, EMA and other Health Authority agencies. Strong understanding cGMP regulations in manufacturing, testing and packaging of drugs;
• Autonomous, sense of responsibility and attention to detail;
• Good interpersonal communications skills;
• Bilingual;
• Good knowledge of the Microsoft office suite.