Qualité projet / Validation SI/Cloud F/H
Core
Strategic and operational partner ensuring compliance of IT/Cloud deliverables and AI projects with strict pharmaceutical regulations (GAMP 5, FDA, EMA, EU Annex 11).
Role type
Senior Project Quality Assurance / IT & Cloud Validation Specialist
Builds
Compliant IT systems, Cloud environments, and AI models for the pharmaceutical/biotech industry
Domain
Pharmaceutical/Biotech Industry, IT Validation, Cloud Computing, AI/ML
Deliverable
production ML models
Required skills
GAMP 5 expertise, Cloud qualification, Risk analysis (FMEA), Change Control management, Regulatory inspection preparation, AI model validation, Vendor audit management
Preferred skills
Knowledge of ERP/SAP, LIMS, MES, QMS systems
Responsibilities
Pilot compliance of deliverables (plans, protocols, reports, URS), Secure change management processes and risk analyses, Evaluate and qualify Cloud vendors, Frame compliance of AI projects (algorithm traceability, bias management), Evolve internal SOPs and quality reference
Seniority
Senior, hands-on IC
