Validavimo komandos vadovas (-ė) | Įrangos kvalifikavimas ir kompiuterizuotų sistemų validavimas – Vilnius
Core
Leading a team responsible for equipment qualification and computerized system validation (CSV) to ensure regulatory compliance and product quality.
Role type
Senior IC validation team lead (equipment qualification & CSV)
Builds
Production ML models | product features | dashboards & analysis | infrastructure
Domain
Life sciences & diagnostics manufacturing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Equipment qualification, Computerized System Validation (CSV), Regulatory compliance (GMP, GxP, ISO, GAMP5), Risk assessment, CAPA management, Change control, Non-conformance management, Team leadership, Strategic planning, Technical documentation
Preferred skills
LIMS/MES/ERP/QMS/SCADA experience, ISO 13485/FDA/ES GMP knowledge, Lean/Six Sigma methodologies, International matrix organization experience
Technologies
LIMS, MES, ERP, QMS, SCADA, EDMS
Responsibilities
Lead validation team and drive strategy, Develop and maintain validation processes and standards, Ensure compliance with GMP/GxP/ISO/GAMP5, Manage full validation lifecycle (DQ/IQ/OQ/PQ), Represent validation in audits and inspections, Collaborate on product and system implementation projects
Seniority
Senior, hands-on IC