Chargé AQ Validation des systèmes informatisés / Data Integrity Officer - F/H (CDI)
Core
Ensure compliance with regulations (GMP, 21CFR Part 11, Annex 11) and group/local procedures for computerized system validation and data integrity at the Strasbourg site.
Role type
Senior Data Integrity Officer / Computerized System Validation Specialist
Builds
Validated computerized systems and data integrity compliant environments for pharmaceutical manufacturing and laboratory operations
Domain
Pharmaceutical CDMO, Biotechnology, GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computerized System Validation (CSV), 21CFR Part 11, EU Annex 11, GAMP5, Risk Assessment, CAPA management, Audit trail review, Access control review, Backup and restore procedures, Data Integrity principles, Regulatory inspection readiness, Supplier audit
Preferred skills
Experience deploying manufacturing or laboratory systems in GMP environments, Internal/External audit experience, Cross-functional collaboration
Technologies
GAMP5, 21CFR Part 11, EU Annex 11, GMP
Responsibilities
Review and approve validation documents, audit trails, access reviews, and backup/restore procedures; Conduct risk assessments with system/data owners; Guide teams on data integrity requirements; Answer questions during regulatory inspections and client audits; Audit supplier validation and data integrity; Maintain regulatory awareness on CSV and data integrity
Seniority
Senior, hands-on IC
