QA Specialist

QA Specialist

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Progenika Biopharma is looking for a Quality Assurance Specialist, to join Quality department.

Responsibilities

Ensure proper handling of complaints: Manage product complaints. Analyze complaints, including risk assessment and determination of reportability to Health Authorities. Conduct and document investigations related to customer complaints. Create and maintain Quality procedures related to complaints. Define and follow up on corrective actions arising from complaints. Perform audits to ensure that cases logged by technicians are correctly classified. Prepare trend reports and monitor complaints. Maintain the vigilance and post-market surveillance system in accordance with applicable regulations: Report adverse events to Health Authorities. Manage product recalls, Field Safety Corrective Actions (FSCA), and Field Safety Notices (FSN) in line with applicable regulations. Participate in the definition of vigilance system procedures. Develop post-market plans, procedures, and reports in compliance with applicable regulations. Maintain a Quality System ensuring compliance with applicable regulations (ISO 13485, IVDR, MDSAP): Actively participate in projects aimed at improving the effectiveness of the Quality System and its operational efficiency. Participate in external quality audits. Generate and monitor post-market indicators within the Quality Management System. Shipment and logistics support: Manage temperature excursions in shipments. Handle documentation required by distributors for shipments. Supplier Management: Participate in the evaluation and qualification process of product and service suppliers, including audits and technical visits. Draft quality agreements with suppliers. Carry out general duties of a Quality Assurance Supervisor: Actively participate in projects aimed at improving the effectiveness of the Quality System or productivity, ensuring compliance with applicable GMPs (ISO 13485, 21 CFR 820, 21 CFR 600, MDSAP, or others) and internal procedures. Plan and propose the acquisition of new resources necessary for the proper execution of assigned responsibilities. Ensure that all documentation related to assigned tasks is always current. Coordinate and supervise the activities of team members, if applicable. Support the Head of Department in various tasks to ensure the effectiveness of the Quality System. Provide user support for the Document Management System (LSQM) and act as a key user for the application.

Qualifications

Bachelor's Degree in Health Sciences (Biology, Chemistry, Pharmacy, Biotecnology, Biochemistry or similar). Desirable to have 3 years of experience in a similar tasks, being in Quality Department of pharma company. High level of English. High knowledge of Office package. Detail and procedure oriented and prioritization skills. Proven collaboration and communication skills as well as ability to work as a team member.

Schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time). Flexibility for U Program: Occasionally remote Benefits package Contract of Employment: Permanent position Location: Derio (Bilbao)