Projektmanager GMP & Compliance in der Radiopharmazie (m/w/d)
Core
Coordinating and implementing GMP-relevant projects to ensure regulatory compliance for the introduction of new facilities, processes, and infrastructures in a radiopharmaceutical production environment.
Role type
Senior GMP & Compliance Project Manager
Builds
New production facilities, cleanroom processes, and laboratory infrastructures for PET diagnostics precursors and kits
Domain
Radiopharmaceuticals / Nuclear Medicine / GMP Compliance
Required skills
GMP requirements knowledge, Qualification and Validation project experience, Radioactive material handling, Risk analysis, Change control, CAPA management, Regulatory documentation
Preferred skills
Experience with external partners coordination, Authority inspection support
Technologies
GMP guidelines, EU-GMP guidelines, Qualification/Validation tools
Responsibilities
Planning and implementation of GMP projects in production/cleanroom/lab, Ensuring GMP-compliant project execution, Creating and reviewing qualification/validation documentation, Coordinating internal and external stakeholders, Supporting risk analysis and change control procedures, Participating in authority inspections and audits