Support validation, user role definition, and data integrity considerations linked to the new documentation framework. * Strong knowledge of GxP, ICH Q10, ISO 9001, and regulatory requirements related to documentation and data integrity. The role is responsible for designing the future‑state QMS documentation architecture, including document hierarchy, metadata model, lifecycle processes (including translation), and governance, ensuring alignment with GxP regulations, industry standards, and internal quality strategy. This position operates in a project context, focusing on definition, design, and standardization, and provides the foundation for future implementation within electronic document management systems (EDMS). * Define the future-state document hierarchy for all QMS procedural documents, including Governance & Procedures, Quality Manual, Policies, SOPs and SOP-Ais, Standards and User Guides-A
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