Computer System Validation

hace 7 meses


Comunidad de 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 PNT

Requerimientos:
Grado en Life Sciences
Experiência 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.

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...



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