Quality Asurance Specialist (m/f/d) – Clinical Supply & QP Support
Core
Support Qualified Persons (QPs) in the certification and release process for clinical trial materials within a GMP/GDP environment.
Role type
Quality Assurance Specialist (Clinical Supply)
Builds
Certificates of Release, Confirmations of Import, QP Declarations, and compliant release documentation for clinical trial supplies.
Domain
Life Sciences / Clinical Supply Chain / Pharmaceutical Quality
Required skills
GMP/GDP knowledge, documentation management, batch release procedures, regulatory compliance verification, SOP maintenance, audit support, CAPA activities, process improvement
Preferred skills
SharePoint, TrackWise, eDMS experience, cross-functional collaboration
Technologies
Microsoft Office, SharePoint, TrackWise, eDMS
Responsibilities
Prepare and review documentation for QP certification and batch release; Coordinate with customers and project teams to track quality documentation; Verify country-specific clinical trial approvals; Support internal audits, client audits, and health authority inspections; Participate in investigations and quality system improvements.
Seniority
Individual Contributor
