Digital Quality, CSV Systems Specialist
Core
Primary business administrator for the Kneat Gx e-validation platform, driving digital transformation of validation processes and ensuring data integrity for computerized systems.
Role type
Senior IC E-Validation System Expert (CSV)
Builds
e-validation platforms and standardized documentation for IT projects and operational validation activities
Domain
Life Sciences / Computer Systems Validation (CSV)
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Computer Systems Validation (CSV), system administration, Kneat Gx, GxP regulations, GAMP 5, 21 CFR Part 11, electronic records management, user access management, training delivery, documentation strategy, audit support
Preferred skills
TrackWise, Document Management Systems (DMS), process optimization, change request execution
Technologies
Kneat Gx, TrackWise, DMS
Responsibilities
Manage user access, role configurations, and permission requests for Kneat Gx; deliver and maintain Kneat training for IT projects and operational validation; assist with system upgrades, periodic reviews, and new template rollouts; create protocols, scripts, and reports for infrastructure and application projects; drive optimization of e-validation records and processes; execute IT projects and change requests by driving documentation within electronic platforms; support internal audits and regulatory inspections; assist with monthly updates, quarterly inspection reports, and regulatory CAPA reports; uphold data integrity principles
Seniority
Senior, hands-on IC