QA Professional
Core
Support development, lifecycle management, and validation of digital tools, computerized systems, and AI-enabled applications for Regulatory Affairs and Quality Assurance operations.
Role type
QA Professional specializing in QMS Digitalization and Computerized Systems Validation
Builds
In-house IT tools, automated workflows, reports, dashboards, and AI-enabled solutions for RAQA processes
Domain
Life sciences, diagnostics, biotechnology, medical devices, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Computerized systems validation (CSV), AI governance, digital tool development, regulatory compliance knowledge, process digitalization, qualification planning, documentation
Preferred skills
None stated
Technologies
None explicitly listed
Responsibilities
Lead and support development, configuration, and deployment of in-house IT tools and AI solutions; Partner with process owners to identify opportunities for process digitalization and automation; Plan, coordinate, execute, and document qualification and validation activities for computerized systems; Act as subject matter expert for digital solutions and AI governance; Provide guidance to process owners within RAQA
Seniority
Mid-level IC (3+ years experience)
