Spécialiste Assurance Qualité Système Compliance - Performance & Gouvernance H/F
Core
Piloter la gouvernance, la performance et l'amélioration continue de quatre processus qualité clés (Change Control, Gestion documentaire, Formation, Archivage) pour un site fabricant pharmaceutique.
Role type
Specialist, Quality System Compliance & Performance
Builds
Quality management processes and regulatory compliance systems
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
dashboards & analysis
Required skills
Change Control management, Document management, Training program governance, Record retention/archiving, KPI definition and tracking, Root cause analysis, Regulatory compliance (GxP), Process improvement methodologies
Preferred skills
Stakeholder influence, Cross-functional collaboration, Data-driven decision making
Technologies
QMS systems, Document management systems, KPI dashboards
Responsibilities
Oversee Change Control process execution and closure, Ensure document system governance and compliance, Manage training curriculum availability and effectiveness, Oversee record retention and data integrity, Define and analyze quality process KPIs, Report performance results to management
Seniority
Mid-level, hands-on specialist