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Csv Senior Specialist, Barcelona

hace 2 meses

Barcelona, España buscojobs España A tiempo completo

CSV Senior Specialist en Barcelona. Perfil buscado (Hombre/Mujer) Llevar a cabo actividades propias de validaciones de sistemas computerizados (SAT/URS/FS/Análisis de Riesgos/IOPQ) para PLCs/ SCADA/ SAP/ DMS/ QMS y hojas de cálculo así como recualificaciones de infraestructuras IT. Mantener y llevar a cabo mejoras encaminadas a la gestión de integridad de datos y la validación de sistemas computerizados conforme al Anexo 11 de las EU-GMP y la 21 CFR part 11 de la FDA. Liderar la implantación de herramientas de gestión IT y mejoras en cuanto a la implementación de planes de contingencia. Definir junto con la dirección indicadores de calidad haciendo propuestas de mejora que deriven en planes de acción. Colaborar con Garantía de Calidad en la homologación de proveedores de IT para asegurar que estos cumplen estándares GxP mediante definición de acuerdos técnicos y de contratos de mantenimiento. Actuar como experto/a en gestión de softwares de gestión y control durante auditorías internas y externas. Participar y liderar investigaciones de desviaciones relacionadas con la integridad de datos así como e implementar acciones correctivas y preventivas (CAPAs) dentro del ámbito de los sistemas informáticos y sus infraestructuras. Construir y gestionar el sistema de calidad de IT (política procedimientos instrucciones de trabajo metodologías gestión ...) alineado con las políticas de calidad del grupo. Mantener el status de los sistemas GxP en Validado mediante la realización de la revisión periódica de sistemas informáticos. Impartir formación regular al personal de IT en los temas de CSQ y CSV Empresa farmacéutica con planta de producción en la provincia de Barcelona Proyecto estratégico y con gran visibilidad Titulación universitaria técnica o grado superior preferiblemente en tecnología informática y/o telecomunicaciones. Conocimiento de principios de seguridad de sistemas gestión de vulnerabilidades y gestión de la infraestructura de sistemas Mínimo 3 años de experiencia en rol similar para instalaciones farmacéuticas/químicas/alimentarias/productos sanitarios. Conocimiento de las regulaciones GxP (GAMP y CFR21 Parte 11). Data Integrity. Conocimiento de metodologías de gestión de proyectos gestión de riesgos optimización de recursos y gestión de prioridades. Inglés fluido oral y escrito. Acostumbrado a trabajar en un ambiente multidisciplinar con pensamiento analítico y atención al detalle. Empresa farmacéutica multinacional busca incorporar a un/a Computer Systems Validation Computer Systems Assurance y Data Integrity Specialist para su planta ubicada en la provincia de Barcelona. Remuneración competitiva en función de la experiencia demostrada. Plan de desarrollo personal acorde a las responsabilidades y objetivos asignados. PLC, SCADA