ppWould 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 general 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. /p pbWe believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding. /b /p pIn our Technical Area Department, we are looking for a QA Product Release Section Manager to manage product release activities for both manufactured and distributed products, ensuring compliance with Technical Direction guidelines and applicable regulatory requirements. /p h3What your responsibilities will be /h3 ul liManage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines. /li liParticipate in the configuration of systems related to product release. /li liCoordinate communications with Notified Bodies, reference laboratories and related stakeholders. /li liManage documentation storage, control and retrieval, including externally archived documentation. /li liHandle document management quality notifications, ensuring proper tracking and workflow. /li liApprove quality notifications after evaluating their impact on batch release and product status. /li liMonitor the status of materials affected by quality notifications.
/li liCoordinate communications with Health Authorities (e.g., AEMPS) and Pharmacy Inspection regarding import/export activities. /li liIssue and manage authorizations and official letters required for import/export processes. /li liEnsure compliance with applicable regulations such as ISO 13485, IVDR and MDSAP. /li liAct as internal auditor and participate in supplier audits. /li liParticipate in continuous improvement of the Quality Management System. /li /ul h3Who you are /h3 ul liBachelor's degree in Enigneering, Health Sciences or similar. /li liAt least 3 years of experience in Quality Assurance or Regulatory Affairs. /li liExperience in regulated environments under ISO13485 and/or IVDR. /li liExperience in team management. /li liExperience in audits. /li liCross‑functional and collaborative work with multiple departments. /li liAttention to detail and compliance. /li liAnalytical ability and technical judgement in impact assessments. /li liEnglish level is C1. /li /ul h3What we offer /h3 pIt is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. /p pWe believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help. /p pGrifols is an equal opportunity employer. /p h3Flexible schedule /h3 pMonday‑Thursday 7‑10 to 16‑19h and Friday 8‑15h (with the same flexible start time). /p /p #J-18808-Ljbffr