Your mission Provide Quality Assurance oversight and guidance for Gx P computerized systems, ensuring compliance throughout their lifecycle—from implementation and validation projects to day-to-day operations. You will serve as a key point of contact for Computerized Systems Validation (CSV) and act as the interface between IT and business teams on e Compliance matters, promoting a culture of quality. Your key responsibilities: Review and approve Gx P applicability assessments and key validation deliverables.

Experiencia, cualificaciones y habilidades interpersonales, ¿tiene todo lo necesario para triunfar en esta ocasión? Descúbralo a continuación.
Review and approve Gx P-impacting changes and deviations, ensuring appropriate CAPAs are implemented. Review and approve Periodic Review Reports and ensure identified gaps are addressed through the CAPA management system. Contribute to the preparation and execution of the Validation Master Plan (VMP). Participate in Gx P supplier qualification activities and provide Quality support for audits and resulting actions.



Advise project and operations teams on CSV and compliance requirements. Support the implementation, operation and optimization of automation and AI-enabled solutions for e Compliance activities.
What we're looking for:
A degree in Information Technology, Life Sciences, Pharmacy, Engineering or an equivalent field. At least 5 years of overall professional experience , with additional experience preferred, including a minimum of 4 years of relevant pharmaceutical industry experience in regulated functions such as IT Quality & Compliance. A strong understanding of CSV, Gx P and 21 CFR Part 11 , as well as Health Authority expectations.
Experience in the implementation, lifecycle management and day-to-day operation of Gx P computerized systems and their supporting technologies. Professional fluency in English , enabling you to work independently, contribute to meetings, review technical documentation and coor

📌 Senior ecompliance specialist (Barcelona)
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📍 Barcelona