Specialist Quality Compliance & Systems (m/w/d)
Core
Ensuring quality compliance and system optimization for the production of contrast media in a pharmaceutical manufacturing environment.
Role type
Quality Compliance & Systems Specialist
Builds
Quality management processes, audit plans, CAPA/CCAs, and training systems for pharmaceutical production
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
GMP knowledge, pharmaceutical manufacturing experience, CAPA management, audit coordination, document management, validation planning, trend analysis, system administration
Preferred skills
SAP proficiency, electronic QM systems (Trackwise, LIMS), MS Office, training management
Technologies
SAP, Trackwise, LIMS, Expresso
Responsibilities
Coordinate internal and external audits, manage CAPA and CCA lifecycle, optimize document management hierarchy, administer training management systems, prepare Quality Management Reviews and PQRs, monitor critical trends and deadlines
Seniority
Mid-level specialist
