Validation Expert

hace 5 meses

Palafolls Barcelona provincia, España Sandoz A tiempo completo

**Tus responsabilidades incluirán**:

- Ejecutar y gestionar actividades de validación y actividades de gestión de cambios para cumplir con los requisitos de cGMP a tiempo y en calidad, garantizando que los programas de validación del site cumplan con las expectativas regulatorias globales
- Gestionar las desviaciones asociadas con las validaciones y hacer recomendaciones para su resolución y prevención de recurrencias
- Redactar y revisar protocolos e informes de validación, así como Risk Assessments asociados
- Ejecutar o dar soporte a la ejecución de actividades de validación
- Planificar o apoyar la planificación de las validaciones del site preparando y gestionando el cumplimiento del Validation Master Plan (VMP)
- Respaldar las actividades del ciclo de vida de la validación del proceso al garantizar que se mantenga un estado de control a través de la Verificación Continua de Proceso (OPV) y proceso de limpieza (OCV). Asegurar que se identifiquen las variables apropiadas para monitorizar y contribuir a las actividades de gestión de riesgos de calidad
- Gestionar las actividades y proyectos bajo su propia responsabilidad

**Qué debes aportar al rol**:

- Estudios superiores en Química o Ingeniería Química
- Conocimiento de procesos y tecnologías de fabricación y validaciones en el entorno de la industria farmacéutica
- Nível de inglés mínimo requerido B2
- Conocimiento de los sistemas de calidad farmacéuticos y los requisitos regulatorios de las autoridades sanitarias
- Experiência en revisión y redacción de informes técnicos, así como de Risk Assessments

**Requisitos valorables**:

- Se valorará positivamente experiência en validaciones de proceso aséptico y esterilizaciones
- Comprensión de los procesos de fabricación y los equipos de proceso e instalaciones relacionadas
- Experiência en gestión de proyectos en un entorno multifuncional
- Mínimo 2 años de experiência en áreas técnicas, como MS&T, R&D o Producción

**Competencias Personales**:

- Capacidad de organización y planificación de tareas
- Capacidad de análisis, creatividad para la toma de decisiones y resolución de incidencias
- Colaboración trabajando en equipos multidisciplinares
- Interés en mejorar continuamente el conocimiento técnico Proactividad, responsabilidad y capacidad de liderazgo

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, innovative production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

Sandoz

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