.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 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.
Responsibilities: Responsible Person (RP) deputy for Spain LOC.
Maintain the AEMPS (National Agency for Medicines and Medical Devices) license of Takeda for Wholesale Distribution of medicinal products and medical devices.
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.
Support key stakeholders in the Iberia MCO on quality matters and initiatives.
Contribute to the achievement of business success.
As Responsible Person (RP) deputy, decide independently from the management about the release, 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.
Develop and maintain GxP-related controlled documents in the LOC Quality Management System.
Track and assess if local documents are compliant with local/global GxP requirements and arrange for necessary actions.
Support GDP implementation at Spain LOC including 3PL oversight.
Ensure all relevant LOC colleagues performing GDP-related tasks are trained before performing activities and on a periodic basis.
Manage submissions of MIF/OCABR for plasma products in LOC Spain/Portugal.
Manage submissions of import/export permits for controlled substances in LOC Spain/Portugal.
Implement Supplier Quality Program at Spain LOC according to Takeda Global Quality requirements and regulatory expectations.
Support local Quality Council, monitor and report key performance indicators (KPIs) according to Takeda Global Quality requirements.
Perform self-assessments to monitor compliance with applicable procedures and requirements