Senior Quality Specialist
hace 3 meses
.By 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 DescriptionAbout 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. Responsible Person (RP) deputy for Spain LOC. Maintain the AEMPS (National Agency for medicines and Medical Devices) license of Takeda (Takeda Farmacéutica España S.A) for Wholesale Distribution of medicinal product and medical devices.How you will contribute:Responsibilities cover GxP-regulated activities including in-country distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing / packaging / analytical testing quality oversight, and in-country clinical and medical device activities.Work 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, decides independently from the management about the release, the block, or recall of batches.Support a harmonized quality approach across the Portugal and Spain LOCs.Support R&D QMS maintenance.Manage GxP regulated activities in Spain LOC to ensure compliance to 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 both for GDP and R&D activities. These include: 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.Ensure all relevant LOC colleagues performing GDPs related tasks are trained before performing activities and on a periodic basis
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