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  • Computer Systems Validation Consultant - Madrid, COMUNIDAD DE MADRID, Spain - Ambit Iberia

    Ambit Iberia
    Ambit Iberia Madrid, COMUNIDAD DE MADRID, Spain

    hace 2 semanas

    Default job background
    Educación / Formación
    Descripción

    Descripcion del Puesto

    Buscamos a un Validation Consultant para unirte a nuestro equipo de LifeScience. Este rol te brindará la oportunidad de participar en proyectos y formaciones innovadoras que marcarán una diferencia.

    Si buscas contribuir con tu experiencia en un equipo innovador, esta es la oportunidad perfecta para ti.

    Responsabilidades

    • Ejecutar protocolos de cualificación y mantener el estado de validación a través de Revision Periódica.
    • Planificar y dirigir proyectos de baja complejidad, según los requisitos del cliente y las normas legales aplicables, para lograr los objetivos estratégicos de la compañía.
    • Resolver consultas de técnicos y clientes, revisar documentación de validación de proyectos liderados y ofrecer asistencia técnica.
    • Contribuir con estudios universitarios avanzados (Ingeniería Química, Ingeniería Industrial, Química, Biología, Biotecnología) y más de 4 años de experiencia en el sector.
    • Experiencia previa en validación de sistemas informatizados y conocimiento de GxP (GMP, GDP) del sector farmacéutico.
    • Familiaridad con pruebas de cumplimiento de 21 CFR Part 11 y EU GMP Annex 11, así como Data Integrity y GAMP 5.
    • Destrezas avanzadas en ofimática con Microsoft Office.
    • Tipo de contrato híbrido: 2 días presenciales y 3 en remoto.
    • Beneficios incluyen ticket restaurante, plan de retribución flexible, seguro médico privado, billete de transporte público y cheque guardería.
    • Acceso a descuentos en gimnasios Wellhub y oportunidades de formación y desarrollo.
    • Bonus de recomendación por referenciar a un candidato calificado.

    Requisitos

    • Estudios universitarios avanzados (Ingeniería Química, Ingeniería Industrial, Química, Biología, Biotecnología).
    • Más de 4 años de experiencia en el sector.
    • Experiencia previa en validación de sistemas informatizados.
    • Conocimiento de GxP (GMP, GDP) del sector farmacéutico.
    • Experiencia en pruebas de cumplimiento de 21 CFR Part 11 y EU GMP Annex 11.
    • Familiaridad con Data Integrity y GAMP 5.
    • Destrezas avanzadas en ofimática con Microsoft Office.

    Cómo Aplicar

    Si eres un profesional motivado y deseas contribuir a un equipo innovador, envíanos tu currículum y carta de presentación para considerar tu candidatura.


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