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Ambit Iberia

Responsable de Validación de Sistemas Informatizados (CSV)

Barcelonaonsite

Posted 1w ago · via Teamtailor

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About this role

REQUISITOS 🤹 : Experiencia previa en Computer System Validation (CSV) dentro del sector farmacéutico o Life Sciences. Experiencia en validación de sistemas informatizados, aplicaciones corporativas e integraciones con impacto GxP. Experiencia en elaboración y ejecución de protocolos de validación, scripts de pruebas, análisis de riesgos e informes. Conocimiento de la normativa GxP del sector farmacéutico. Conocimiento de las normativas 21 CFR Part 11 y EU GMP Annex 11. Conocimiento de GAMP 5 y de metodologías de validación basadas en riesgos. Experiencia en gestión de cambios ( Change Control ), desviaciones y acciones correctivas y preventivas (CAPA). Conocimiento de integridad de datos, registros electrónicos y audit trails.…

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What we'd score you on

reqspace match rubric

Five dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.

1

Skills match

We compare your skills against the role requirements.

2

Level fit

We check your title trajectory against the seniority signal of the role.

3

Domain experience

Your work in the role's domain matters more than your years total. We weight recent and direct experience.

4

Recency

A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.

5

Location fit

This role is based in Barcelona. We weight your proximity and willingness to relocate.

Score yourself on this role.
Free · no card · written explanation included
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