Equipment & Process Validation Manager

hace 4 días


Barcelona, España Haema A tiempo completo

¿Quieres unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud?
¿Quieres mejorar la vida de millones de personas?
Grifols es una compañía global del sector de la salud que, desde su fundación en Barcelona en 1909, trabaja para mejorar la salud y el bienestar de las personas en todo del mundo.
Nuestras cuatro divisiones -Bioscience, Diagnostic, Hospital y Bio Supplies
- desarrollan, producen y comercializan medicamentos, soluciones y servicios innovadores en más de 100 países y regiones.
**Únete a Grifols
**

Como Equipment and Process Validation Manager, tu misión será preparar y ejecutar protocolos de puesta en marcha y cualificación de equipos de la planta, instalaciones, servicios, sistemas de control de procesos, sistemas informáticos, validación de limpieza y validación de procesos de la planta, así como supervisar las actividades de varios proyectos de validaciones gestionados por técnicos de validaciones.
**Cuáles Serán tus Responsabilidades**
- Gestionarás los proyectos de validación de procesos y equipos asignados por el responsable del departamento.
- Planificarás y gestionarás los recursos humanos y materiales necesarios, para cumplir los objetivos dentro del plazo y presupuesto establecidos.
- Coordinarás las actividades de validación, incluyendo su planificación y programación.
- Proporcionarás soporte de validación y planificación a los departamentos de Producción, Ingeniería, IT, QA y QC y asistencia en la generación de URS, documentos de cualificación, validación y otros relacionados con la validación de equipos, servicios y sistemas, así como protocolos de procesos de fabricación e informes finales.
- Realizarás diferentes análisis de riesgos de equipos/procesos.
- Ejecutarás las diferentes pruebas de validación y revalidación.
- Solucionarás incidencias relacionadas con las validaciones.
- Asistirás en la investigación y resolución de las CAPAs en relación con las validaciones de proceso y limpieza.
- Elaborarás documentos (informes, flujos etc) a petición de normativas y registros.
- Darás soporte en auditorías de los diferentes organismos reguladores.
**Quién eres**
- Tienes** **Licenciatura en Farmacia, Ingeniería, Biología, Química, Bioquímica o disciplina científica / técnica relacionada.
- Dispones de más de 4 años en la planificación/organización/ejecución de actividades de cualificación y validación, seguimiento de resultados y resolución de problemas complejos con equipos multifuncionales
- Conoces las directrices actuales GMP, ISPE, GAMP 5 e ICH.
- Tienes experiência en la gestión y supervisión de proyectos de validación y relaciones con las agencias reguladoras.
Además, en cualificación de: instalaciones, servicios, equipos de fabricación, equipos automatizados, validación de procesos de producción y limpieza y sistemas informáticos.
- Hablas un nível avanzado de inglés.
- Tienes iniciativa y capacidad de liderazgo.
**Qué Ofrecemos**
- Contrato Indefinido.
- Ubicación: Parets del Vallés.
Formar parte de Grifols significa la oportunidad de trabajar en un entorno de proyección internacional dónde se promueve la igualdad de oportunidades.
Significa la oportunidad de desarrollarte profesionalmente, de disponer de formación continua y de integrarte en un equipo de profesionales en el que la aportación individual de cada uno cuenta.
Nuestro compromiso es mantener un entorno que favorezca el desarrollo profesional de nuestros empleados en un buen ambiente de trabajo.
El capital humano de Grifols es clave tanto en el desarrollo de las actividades como en el proceso de expansión de la compañía.
**Ubicación**:mfield6**:cust_building**

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