Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start date: as soon as possible
Duration: 31.12.27
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.
