QA Release

hace 7 meses

Sant Cugat del Vallès Barcelona provincia, España Boehringer Ingelheim España, S.A. A tiempo completo

**QA Release & Compliance Officer**:
Dentro del área de QA Inyectables y Orales, reportando directamente al Responsable de Release & Compliance, el QA Release&Compliance officer I&O será responsable de realizar las siguientes tareas.

**Tareas y responsabilidades**:

- Recopilar, organizar y completar la documentación establecida para cada lote fabricado en BIESA. Revisar la documentación para asegurar que los lotes han sido fabricados de acuerdo con las GMPs, con los estándares de Boehringer Ingelheim y con el resto de las normativas aplicables.
- Revisión y monitorización del estado de las desviaciones con impacto en producto asegurando que se encuentran cerradas con anterioridad a la liberación de los lotes, así como otros requerimientos relacionados (validaciones de proceso, controles de cambio).
- Dar soporte en la evaluación y gestión de eventos /incidencias que afecten a la liberación de lotes.
- Asegurar el cumplimiento GMP y regulatorio de todos los documentos y flujos de trabajo asociados mediante la elaboración, revisión y aprobación de contenidos documentales (SOP).
- Asegurar el cumplimiento GMP y regulatorio de todos los documentos y flujos de trabajo asociados mediante la elaboración, revisión y aprobación de contenidos tanto documentales como del sistema ERP (Master Data, recetas maestras, Normas, Estructuras, Prescripciones, PQR).

**Requisitos**:

- Titulación universitaria en Química, Bioquímica, Farmacia o Grado Equivalente
- Muy valorable conocimiento y habilidad informática
- Experiência de más de 2 años en industria farmacéutica.
- Inglés fluido hablado y escrito.
- Rápida adaptación a los cambios, flexibilidad y rápida capacidad de aprendizaje, autónoma y con buenas habilidades de comunicación y empatía.

IamBoehringerIngelheim porque

Estamos continuamente trabajando porque queremos diseñar para ti la mejor experiência. Estos son algunos ejemplos de cómo te cuidaremos:

- Horario flexible
- Seguro de vida y accidente
- Seguro médico a un precio competitivo
- Inversión en formación y desarrollo
- Cuidado de la salud
- Portal de ofertas para colaboradores
- Smartworking

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