Qualitätsmanagement Spezialist (m/w/d)
Core
Support the development and maintenance of the Quality Management System (QMS) and digital QMS (eQMS) to ensure regulatory compliance and continuous process improvement.
Role type
Quality Management Specialist
Builds
Quality Management Systems (QMS) and digital QMS (eQMS)
Domain
Life Sciences / Pharmaceutical / Regulated Industries
Deliverable
dashboards & analysis
Required skills
Quality Management Systems (QMS), digital QMS (eQMS), CAPA management, Change Control, root cause analysis, audit preparation, supplier qualification, regulatory compliance (GDP/GMP), KPI analysis, MS Office
Preferred skills
Experience with MasterControl or Ideagen, internal/external audit experience
Responsibilities
Maintain and optimize the QMS and eQMS; process deviations, complaints, CAPAs, and change controls; analyze KPIs and drive improvements; participate in validation and qualification activities; support internal and external audits; qualify and evaluate suppliers; create reports and presentations for management.
Seniority
Mid-level, hands-on IC