Takeda Pharmaceuticals Senior Quality SpecialistMadrid, SpainApply NowBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job Description About the Role:As the Senior Quality Specialist, you will support the achievement of business success with regards to GDP and quality related activities in the MCO. You will act as the Responsible Person (RP) deputy for Spain LOC and maintain the AEMPS (National Agency for medicines and Medical Devices) license of Takeda (Takeda Farmacéutica España S.A) for Wholesale Distribution of medicinal products and medical devices.How you will contribute: Responsibilities cover GxP-regulated activities including:In-country distribution qualityLocal Health Authority relationshipsLocal quality surveillanceLocal contract manufacturing / packaging / analytical testing quality oversightIn-country clinical and medical device activitiesWork in collaboration with other GxP and non-GxP functions focusing on patient's needs, regulatory compliance, and internal standards and SOPs and continuous improvement. Key stakeholders support in the Iberia MCO on quality matters and initiatives. Contribute to the achievement of business success.As Responsible Person (RP) deputy, you will decide independently from management about the release, the block, or recall of batches. Support a harmonized quality approach across the Portugal and Spain LOCs. Manage GxP regulated activities in Spain LOC to ensure compliance with Takeda requirements & local regulations and the supply of quality & compliant products to patients promptly.Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating Procedures (SOPs) that are aligned with local requirements. Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures at the LOC for both GDP and R&D activities. This includes: change control, deviation, CAPA management, training, document management, complaint handling, vendor audits, internal audits & self-inspections, and KPI adherence oversight.Develop and maintain GxP related controlled documents in the LOC Quality Management System. Ensure that LOC QMS is implemented and aligned with our needs, including a contribution for development and review of QMS documents. Track and assess if local documents are compliant with local/global GxP requirements and arrange for necessary actions, such as consultation with subject matter experts and creation/update of processes and applicable training. Support GDP implementation at Spain LOC including 3PL oversight.#J-18808-Ljbffr