Junior Analyst In An Advisory Firm In Mallorca Or Remote

KION Group; Comunidad Valenciana; Presencial; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

Una empresa innovadora está buscando un Especialista Senior en Calidad para liderar iniciativas de aseguramiento de calidad en España. En este rol, serás responsable de garantizar el cumplimiento de las normativas de calidad, gestionando actividades GxP y colaborando con diversas funciones para mejorar continuamente los estándares. Con un enfoque en la atención al paciente y el cumplimiento regulatorio, tendrás la oportunidad de impactar en la calidad de los productos farmacéuticos. Si tienes un máster en farmacia y experiencia en el sector, esta es tu oportunidad para unirte a un equipo que transforma la atención al paciente.

Formación

• 5 años de experiencia en la industria farmacéutica en un entorno de aseguramiento de calidad.
• Conocimiento profundo de las regulaciones locales y de la UE relacionadas con QA.

Responsabilidades

• Supervisar actividades reguladas por GxP y asegurar el cumplimiento de normativas.
• Coordinar la implementación de estándares de calidad globales y procedimientos operativos estándar.

Conocimientos

Aseguramiento de calidad

Regulaciones de la UE

Comunicación con autoridades locales

Gestión de calidad

Fluidez en inglés

Educación

Máster en Farmacia

Herramientas

Sistema de Gestión de Calidad

Descripción del empleo

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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. 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 product and medical devices.

How you will contribute :

1. 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.
2. 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.
3. Key stakeholders support in the Iberia MCO on quality matters and initiatives. Contribute to the achievement of business success.
4. As Responsible Person (RP) deputy, decides independently from the management about the release, the block, or recall of batches.
5. Support a harmonized quality approach across the Portugal and Spain LOCs.
6. 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.
7. Coordinate the implementation of Global Quality Management System (QMS) Standards and Standard Operating procedures (SOPs) that are aligned with local requirements.
8. Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures at the LOC both for GDP and R&D activities.
9. Develop and maintain GxP related controlled documents in the LOC Quality Management System.
10. Ensure that LOC QMS is implemented and aligned with our needs, including a contribution for development and review of QMS documents.
11. Support GDP implementation at Spain LOC including 3PL oversight.
12. Manage submissions of MIF / OCABR for plasma products in LOC Spain / Portugal.
13. Implement Supplier Quality Program at Spain LOC according to Takeda Global Quality requirements and regulatory expectations.
14. Perform self-assessments to monitor compliance with applicable procedures and requirements.
15. Manage inspections / audits and ensure LOC audit / inspection readiness.
16. Lead or support local Health Authority communication on product quality issues.
17. Maintain oversight of contracts and quality agreements on LOC level.
18. Support regulatory surveillance and intelligence in the Spanish LOC for new or emerging regulations.
19. Ensure release to market activities in the Spain / Portugal LOCs are performed to enable continuous market supply.
20. Support any GDP / GxP quality related activities across the Iberia MCO.

What you bring to Takeda :

1. Pharmacy master degree.
2. 5 years on job experience in Pharmaceutical company in QA environment.
3. Experience and proven track record in quality assurance and deep understanding of EU and local laws, regulations and Industry codes related to QA.
4. Fluent in written and spoken English.
5. Deep understanding of LOC / Commercial Quality requirements.

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Locations: Madrid, Spain

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time