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Quality Assurance Manager
hace 4 meses
Asegurar 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 responsabilidades
• Aprobar 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 indefinida
GP - 6
Turno central
FormaciónGrado en Farmacia
Conocimientos específicos
• Conocimientos específicos de GMP's.
• Conocimientos de Normativa FDA-CFR21
• Conocimientos de sistema Trackwise
• Conocimientos de sistema EDMS
• Inglés avanzado
- Experiencia mínima de 2 años en QA en un entorno de producción en industria químico-farmacéutica.
- Valorable experiencia previa como Qualified Person.
• Care: 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.