Mitarbeiter Qualitätsmanagement - Pharma (m/w/d)
Core
Ensuring quality compliance and process optimization in a radiopharmaceutical manufacturing environment.
Role type
Quality Management Specialist (Pharma)
Builds
GMP-compliant radiopharmaceuticals for nuclear medicine diagnostics and therapy
Domain
Pharmaceutical manufacturing / Radiopharmaceuticals
Required skills
GMP compliance, deviation management (AWM), CAPA processes, risk analysis (RiAs), document qualification, GMP documentation, audit support, process optimization
Preferred skills
IT affinity, independent coordination, cross-functional understanding
Technologies
GMP documentation systems, audit tools
Responsibilities
Review and process deviation management (AWM) and CAPA processes; Monitor risk analysis (RiAs); Review quality-relevant documents and qualification documentation; Create/edit GMP documents including Contaminations-Control-Strategy (CCS); Participate in internal/external audits and self-inspections; Optimize documentation structures and paper-based GMP processes; Support routine QM tasks like MediaFills and Batch Record review
