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. * 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 * Ensure alignment between the document hierarchy and ICH Q10, GxP, ISO standards, and internal quality governance principles. * Design and document a standardized metadata framework for QMS procedural documents, including : Naming conventions, Versioning rules, Classification attributes, Ownership and governance fields - Roles, Responsibilities & Governance (RACI) * Define and document clear roles and responsibilities for all stakeholders involved ...
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