From: Ukraine
Location: Kharkiv, UA
On Useme since 7 March 2025
About me
Regulatory Compliance Lead & Quality Architect. Risk-based CSV validation kits and validation-by-design frameworks for inspection-ready, compliant systems.
📋 Focus on regulated environments (GAMP 5, GxP, CFR Part 11, EU Annex 11, ISO 13485): 🔹 Development of Computerized System Validation (CSV) documentation packages for GxP-regulated SaaS and laboratory systems, covering Validation Plans, Test Protocols (IQ/OQ/PQ/DQ), Traceability Matrices, and Validation Summary Reports. 🔹 Creation and maintenance of Validation Master Plans (VMPs) defining validation scope, organizational roles, lifecycle strategy, and change-control governance across systems or sites. 🔹 Implementation of Quality Management Systems (QMS) aligned with ISO 9001, ISO 13485, and 21 CFR Part 11, including document control, CAPA, and audit readiness. 🔹 Application of Quality Risk Management (QRM) methodologies (per ISO 14971, GAMP 5) to evaluate and mitigate data integrity and system risks throughout validation and operation.