Certification & Stability Group Lead

hace 4 meses

Salamanca, España Msd A tiempo completo

Buscamos un responsable para liderar un equipo de nueva creación de Certificación/Estabilidad. Sus funciones se desarrollarán en el marco de Calidad relacionadas con los procesos de Certificación y Estabilidad de la planta de Salamanca, y trabajará en estrecha colaboración con la Dirección de Calidad de la Planta para contribuir activamente en la supervisión de la gestión de la Calidad y procesos de certificación/liberación.

Buscamos una persona con alta motivación y pasión por la gestión de personas, cuyo cometido fundamental será garantizar que las actividades relacionadas con la Certificación y Estabilidad del producto cumplan con las buenas prácticas de manufactura, las políticas corporativas y los requisitos regulatorios establecidos.

**Funciones principales del puesto**:

- Liderar y gestionar el equipo a su cargo: formando, apoyando y evaluando.
- Garantizar el cumplimiento de las normas de correcta fabricación y políticas internas aplicables. Participación en auditorías regulatorias, internas y autoinspecciones.
- Será responsable de las liberaciones/certificaciones de los lotes de producto final de los diferentes IPTs, conociendo las pruebas de producto y el proceso productivo, en estrecha colaboración con el área de Producción y con los QA-IPTs correspondientes.
- Será responsable de coordinar la elaboración, revisión y miembro de calidad en procesos relacionados con las actividades de Certificación/Estabilidad del Sistema de Calidad: eventos, desviaciones, fuera de especificaciones, CAPAs, Controles de Cambio, etc.

**Formación y experiência**:

- Formación universitaria en Ciencias de la Salud.
- 5 años experiência profesional relevante en el sector farmacéutico.
- Conocimiento avanzado en Normas de Correcta Fabricación, Farmacopeas aplicables y de herramientas del Sistema de Calidad*, Gestión de Riesgos para la Calidad y Mejora Continua
- Experiência demostrable en certificación/liberación de producto.
- Experiência demostrable en participación en proyectos, transferencias y auditorías.
- Conocimiento avanzado de inglés y español.
- Se valorará master en gestión de la industria farmacéutica o similares.
- Se valorará experiência previa gestionando equipos en la industria farmacéutica
- Controles de cambios, gestión de desviaciones, fuera de especificaciones, cualificación de equipos, validación de procesos, validación de producto, elaboración de análisis de riesgos, revisiones anuales de producto, reclamaciones, autoinspecciones, etc.

**Conocimientos técnicos**:

- Conocimiento avanzado en los procesos de fabricación de producto, equipos e instalaciones. Se valorará experiência en la fabricación de productos biológicos y estériles.
- Conocimiento avanzado en Normas de Correcta Fabricación y Farmacopeas aplicables.
- Conocimiento avanzado de herramientas del Sistema de Calidad (controles de cambios, gestión de desviaciones, fuera de especificaciones, cualificación de equipos, validación de procesos, validación de producto, elaboración de análisis de riesgos, revisiones anuales de producto, auditorías, etc.).
- Conocimiento y experiência en certificación/liberación de producto.
- Conocimiento en gestión de especificaciones de producto.
- Conocimiento en revisión e interpretación de dossier de producto.
- Conocimiento VICH GL17 y guias Eudralex de la estabilidad de productos farmacéuticos.
- Conocimiento sobre transferencia de productos.
- Conocimiento medio en herramientas de mejora continua.
- Conocimiento en sistema de gestión de materiales y productos: ERP SAP

**Secondary** Language(s) Job Description**:
**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R291876

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