UCB is an international biopharmaceutical company specializing in the therapeutic areas of neurological disorders and immunology. Its Bulle site brings together the Swiss commercial subsidiary and a primary production platform that combines biotechnology and chemistry for the manufacturing and distribution of pharmaceutical specialties used in the treatment of allergies, epilepsy, and autoimmune diseases.

We are seeking a QA Specialist ? eDI & Qualification to act as the primary electronic data integrity (eDI) expert at the UCB Bulle facility, backed by solid expertise in CSV and equipment qualification. In this on-site role, you will enforce ALCOA++ standards through shop-floor Gemba checks and risk assessments, while approving critical qualification deliverables to ensure end-to-end GxP compliance.

Your key responsibilities:

Serve as the local QA authority for electronic data integrity (eDI), establishing robust data governance and enforcing ALCOA++ principles across all systems.
Define, challenge, and review data integrity risk assessments, audit trail review strategies, and user access management frameworks.
Perform proactive eDI Gemba walks and shop-floor spot checks to detect compliance gaps and verify data handling practices in real time.
Monitor eDI compliance indicators and KPIs, analyze trends, and coordinate targeted corrective initiatives with system owners.
Review and approve GxP deviations, root-cause investigations, CAPAs, and change controls involving electronic records and computerized systems.
Deliver site-wide coaching and training on eDI expectations to embed a resilient data integrity culture across operational teams.
Review and approve qualification and CSV deliverables (protocols, testing evidence, reports) across the equipment and software lifecycle.
Author, optimize, and maintain QMS documents, including data integrity procedures, validation SOPs, and work instructions.
Support site readiness for internal audits and regulatory inspections by presenting eDI evidence and following up on commitments.

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