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 serve 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 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 needs, regulatory compliance, internal standards, SOPs, and continuous improvement.
Support key stakeholders in the Iberia MCO on quality matters and initiatives.
As Responsible Person (RP) deputy, decide independently from management about the release, 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 with Takeda requirements and local regulations, ensuring the supply of quality and 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 with quality standards and procedures at the LOC for both GDP and R&D activities, including 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 contributing to the 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 GDP-related tasks are trained before performing activities and on a periodic basis.
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