Role DescriptionAs Senior QA Specialist you’ll be joining a newly formed team in which people of all backgrounds and experiences are respected, and where working together focused on saving lives, by finding the cure for cancer, is a daily activity. You will work cross functionally to execute and improve the Supplier Quality Management (SQM) program. Your responsibilities will include auditing, establishing and updating QTA’s, managing SCARs and coordinating assessment and implementation of supplier changes for raw material and component suppliers.
Responsibilities- Assist in management and enhancement of supplier qualification process that will use risk-based tools for classification, qualification and monitoring. - Assist in audits of and manage audit closure for suppliers: raw materials and component suppliers, contract labs, service providers, specialty couriers and 3PLs. - Assist in developing and reviewing supplier QTAs (in collaboration with Legal and Supply Chain) and establish a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed. - Collaborate with spec development team to execute specification development process to create/change GMP part numbers, specifications and associated Item Master in Oracle EBS for raw materials and components. - Assist in the management and execution of supplier change management system for raw materials and components, testing material specifications (TMS). - Assist in the management and execution of supplier change management system for contract labs, and GMP service providers. - Assist in maintaining the audit schedule and approved supplier list (Oracle Agile and EBS) for assigned suppliers. - Act as Quality contact for supplier issues and discrepancies (SCARs), and assist in the investigations to resolve the issues. - Participate in selection and qualification of new suppliers. - Perform metrics monitoring and refine metrics as needed. - Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
Requirements- Bachelor’s degree in biological sciences or Materials Science with minimum of 6 years of experience in a pharmaceutical or bio supplier quality management role; bio or vaccines experience preferred - Experience in assisting in auditing suppliers for raw materials, sterile components, primary and secondary packaging components and sterilization facilities. - Experience in identifying, writing, evaluating and closing investigations. - Working knowledge of and ability to apply GMP in conformance to US, EU and ROW standards.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.