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hace 3 meses
MisiónAsegurar que los Sistemas de Calidad de las plantas farmacéuticas de producción cumplen con las GMPs y las políticas de Calidad Corporativas de Almirall con el fin de garantizar la seguridad, eficacia y calidad de sus productos farmacéuticos.Funciones y responsabilidadesAprobar la documentación operativa para la fabricación y control de productos farmacéuticos.Revisar la documentación generada en los procesos de la planta verificando su correcta adecuación y cumplimentación.Realizar auditorías periódicas para verificar el nivel de cumplimiento de las GMP en los procesos de fabricación y control de la planta.Realizar auditorías frente a unidades sanitarias y / o partners así como onflor.Evaluar los cambios desde el punto de vista de afectación sobre la calidad del producto y respecto el nivel de compliance de las GMP.Aprobar todos los cambios y someter a aprobación adicional del QA Mánager aquéllos evaluados como significativos.Participar en la investigación de las desviaciones de proceso respecto a los estándares definidos, así como en las reclamaciones del mercado por motivos de calidad.Someter a aprobación del QA Mánager toda desviación evaluada como significativa o reclamación procedente.Efectuar el seguimiento de las medidas correctivas y preventivas.Revisar la globalidad de registros que componen el Batch Manufacturing Record para la liberación al mercado por parte de la Dirección Técnica Farmacéutica.Supervisar el cumplimento de las normas de seguridad y medioambiente por parte de los colaboradores en su ámbito de responsabilidad, así como identificar situaciones o actuaciones que puedan implicar un riesgo en los procesos.Información Adicional:Posición indefinidaJob grade 7 - ManagerTurno centralFormaciónGrado en FarmaciaConocimientos específicosConocimientos específicos de GMP's.Conocimientos de Normativa FDA-CFR21Conocimientos de sistema TrackwiseConocimientos de sistema EDMSInglés avanzadoExperienciaExperiencia mínima de 2 años en QA en un entorno de producción en industria químico-farmacéutica.Valorable experiencia previa como Qualified Person.ValoresCare : escuchamos y sentimos empatía, valoramos las diversas perspectivas y orígenes y nos ayudamos mutuamente a tener éxito.Courage : desafiamos el status quo, asumimos la responsabilidad total y aprendemos de nuestros éxitos y fracasos.Innovation : ponemos al paciente y al cliente en el centro, creamos soluciones novedosas y potenciamos mentalidades emprendedoras.Simplicity : actuamos con decisión y evitamos el análisis excesivo, entendemos por qué antes de actuar y somos ágiles y mantenemos las cosas simples.#J-18808-Ljbffr
