Quality System Specialist
Core
Ensure compliance with GMP/GDP regulations and manage the Quality Management System for respiratory products and third-party suppliers.
Role type
Quality System Specialist (Pharmaceuticals)
Builds
Quality Management System, deviation/CAPA systems, vendor qualification processes, and regulatory documentation.
Domain
Healthcare / Pharmaceuticals / Respiratory products
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP knowledge, deviation management, root cause analysis, CAPA implementation, change control management, vendor qualification, GxP documentation review, electronic QMS proficiency
Preferred skills
TrackWise system experience, supplier performance management, risk assessment, SOP development
Technologies
TrackWise
Responsibilities
Review third-party GxP documentation for batch disposition; manage product complaints and deviation systems; coordinate change controls; maintain Quality Technical Agreements; manage product returns; conduct annual supplier/customer assessments; maintain MAH systems and PQRs; support self-inspections; provide KPIs to management.
Seniority
Mid-level, hands-on IC
