QA Release

hace 5 días

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

Dentro del área de Quality Assurance de la planta de producción Inyectables y Orales, reportando directamente al Responsable de Release & Compliance, el/la técnico/a QA Release & Compliance Officer I&O será responsable de asegurar la calidad de los diferentes lotes producidos/envasado en la compañía.

**Funciones y responsabilidades**:

- Recopilar, organizar y completar la documentación establecida para cada lote fabricado/envasado.
- 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.
- Monitorizar y comprobar el 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 e 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), cómo del sistema ERP (Master Data, recetas maestras, Normas, Estructuras, Prescripciones, PQR).

**Requisitos**:

- Grado Universitario en Química, Bioquímica, Farmacia y/o equivalente.
- Experiência mínima de 2 años en Industria Farmacéutica, especialmente en el departamento de calidad.
- Muy valorable conocimientos de sistemas de guías electrónicas MES y asociados (GoTrack, Veeva Vault, CPD3 )
- Inglés fluido hablado y escrito.Excelentes habilidades de autonomía, comunicación y asertividad, trabajo en equipo, adaptación al cambio, flexibilidad, orientación al detalle, capacidad analítica y rápido aprendizaje.

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