QA eDI & Qualification Specialist

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 and 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.

What will make you successful: - Minimum 5 years of QA experience in pharma/biotech (medical devices or fine chemicals considered), with specialized expertise in electronic data integrity (eDI). - Demonstrated mastery of global data integrity regulations, ALCOA++ principles, audit trail review mechanisms, and electronic record/signature controls. - Solid, hands-on background in equipment qualification and computerized system validation (CSV) under GMP requirements. - Proven track record managing data-related deviations, root-cause investigations, CAPAs, and change controls within a structured QMS. - Familiarity with automated systems, MES, DCS, or analytical laboratory equipment is a strong plus. - Full professional fluency in both French and English (oral and written), including strong scientific/technical writing ability. - Autonomous, well-organized team player with strong negotiation skills, able to challenge practices constructively and manage multiple deadlines in an agile environment. Additional information: - This position is primarily based on-site at the UCB Bulle facility to ensure direct shop-floor oversight and operational proximity. Remote work is limited to a maximum of one flexible day per week depending on business needs (with some weeks requiring 100% on-site presence). travailler chez UCB null