Specialist Operations

hace 7 días


Salamanca, España Merck Gruppe - Msd Sharp & Dohme A tiempo completo

Job DescriptionBuscamos un técnico motivado y con experiencia comprobada en el Área, responsable coordinar y ejecutar las actividades de cualificación de equipos y sistemas utilizados en la planta de producción, para garantizar que las actividades relacionadas con la calidad del producto cumplan con las GMP, los requerimientos y expectativas de los clientes y del mercado.Sus funciones se desarrollarán en el marco de la operativa de Planta, así como nuevas instalaciones y proyectos, para actuar como coordinador en los procesos de cualificación, ejecutando y apoyando a las áreas productivas aplicables, para contribuir activamente en la entrega al cliente.Responsabilidades:Coordinador en los procesos de cualificación, ejecutando el plan y apoyando a las áreas productivas aplicables.Colaborar en el cumplimiento del plan maestro de cualificación, bajo las buenas prácticas de manufactura y políticas internas aplicables, coordinando con las distintas funciones de operativa de Planta las acciones para su ejecución.Apoyo en la ejecución del plan de auditorías regulatoria, interna y de autoinspección.Elaboración, revisión en procesos relacionados con el Sistema de Calidad: eventos, desviaciones, fuera de especificaciones, CAPAs, Controles de Cambios, etc.Mantener actualizado el sistema documental: redacción, revisión de SOP y otros documentos internos bajo su responsabilidad.Calificaciones:Licenciatura universitaria en Ciencias de la Salud o Ingeniería.3 años de experiencia profesional relevante en el sector farmacéutico.Conocimiento de Buenas Prácticas de Manufactura.Experiencia demostrable en participación en proyectos y auditorías.Alto conocimiento de inglés y español.Otros conocimientos:1. Conocimiento de las herramientas del Sistema de Calidad (controles de cambios, gestión de desviaciones).2. Conocimientos en cualificación de equipos y sistemas, procesos de validación, preparación de análisis de riesgos, etc.#J-18808-Ljbffr



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