Senior eCompliance & CSV QA Lead

Motum Technologies

Barcelona

On-site

EUR 60,000 - 90,000

Full time

25 hours ago

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Job summary

Motum Technologies seeks a Quality Assurance professional to provide oversight for GxP computerized systems across their lifecycle, from validation to daily operations. You will be the CSV liaison between IT and business teams, promoting a culture of quality.

The role emphasizes review and approval of validation deliverables, CAPA-driven improvements, and participation in VMP and supplier qualification activities, with a focus on AI-enabled eCompliance solutions.

Qualifications

Degree in IT, Life Sciences, Pharmacy, Engineering or equivalent.
At least 5 years of overall professional experience, including 4 years in pharma in regulated IT quality & compliance.
Strong understanding of CSV, GxP and 21 CFR Part 11.
Experience implementing, lifecycle managing and operating GxP computerized systems.
Professional fluency in English.

Responsibilities

Review and approve GxP applicability assessments and key validation deliverables.
Review and approve GxP-impacting changes and deviations, ensuring CAPAs are implemented.
Review and approve Periodic Review Reports and address identified gaps via CAPA management.
Contribute to the Validation Master Plan (VMP) preparation and execution.
Participate in GxP 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 eCompliance activities.