Senior Quality Specialist, Portugal/Iberia

Detalhes da Vaga

.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 OBJECTIVES/PURPOSE Support the achievement of business success with regards to GDP and quality related activities in the MOC (Multi-Country Organization). Responsible Person (RP) for Portugal LOC (Local Operating Company). Maintain the INFARMED (National Agency for medicines and Medical Devices) license of Takeda (Takeda Farmacêuticos Portugal LDA) for Wholesale Distribution of medicinal product 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, as well as internal standards and SOPs and continuous improvement. Serves as the Quality point of contact in the Portugal LOC on quality matters and initiatives. Contribute to the achievement of business success. As Responsible Person (RP), decides independently from the management about the release, the block, or recall of batches. Take other QA relevant decisions independently, as needed. Supports a consistency and harmonized quality approach across the Portugal and Spain LOCs. Contribute to R&D system maintenance. ACCOUNTABILITIES Manage GxP regulated activities in Portugal LOC to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner. 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. These include but are not limited to change control, deviation, CAPA management, training, document management, complaint handling, etc as well as 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 the needs of the organization, 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 effective GDP implementation at Portugal LOC including 3PL oversight


Salário Nominal: A acordar

Fonte: Jobtome_Ppc

Função de trabalho:

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