Computer System Validation

hace 1 semana


Madrid, Madrid, España Walters People A tiempo completo
Desde Walters people, estamos buscando un Ténico de Validación de Sistemas Informáticos para unirse al equipo de una importante compañia CMO dedicada a la fabricación de fármacos y suplementos alimenticios, en crecimiento y constante evolución, por lo que buscamos profesionales que quieran y desarrollar su carrera

Responsabilidades:

  • Colaboración en el cumplimiento de GxP, especialmente en la Validación de Sistemas Informatizados.
  • Gestión de la documentación de validación (Plan de Validación, Evaluación de Riesgos, Requisitos, Protocolos, scripts de pruebas, etc), ejecución de pruebas y elaboración de informes.
  • Garantizar que todas las cuestiones y desviaciones relacionadas con el proyecto se registran, aprueban y dispensan en consecuencia (incluida la garantía de la preparación y aprobación del informe de desviación adecuado)
  • Preparación de los informes y revisión/aprobación de todos los demás documentos para garantizar el cumplimiento de los PNTRequerimientos:Grado en Life SciencesExperiência de trabajo en el entorno farmacéutico y conocimiento del negocio farmacéutico y químico, fabricación y procesos de calidad (cumplimiento de GxP, validación y gestión de sistemas de calidad, GMP Anexo 11, 21CFR parte 11).Experiência en sistemas informáticos, automatización y programación.
Muy valorable experiência en CSV, especialmente en sistemas ERP, EDMS; EQMS.

Ofrecemos:

  • Beneficios: Salario competitivo según experiência
  • Trabajo en equipo: personal altamente cualificado con numerosos años de experiência, siempre disponible para ayudar.
  • Flexibilidad horaria y 20 días de teletrabajo anuales.


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