Preparation of high quality CMC regulatory documentation and contribution to global regulatory submissions and strategies
GMP-compliant, efficient implementation and documentation of the qualifications of equipment for Microbiology laboratory
Technical design and standards for packaging equipment, (secondary and tertiary) packaging technical transfer and new product launch projects
Selbständige Durchführung von Qualifizierungen
Quality Project Management support on IMP (investigational medical product) for planning, scheduling and reporting.
Participate in cross-functional technical projects to provide technical expertise to commercial aseptic drug product manufacturing activities
In this position as Project Manager you will work in different master data projects.
Support the establishment of a world-class packaging organization by providing technical expertise in the development of new packaging systems.
Verantwortung für das Dispensieren und Bereitstellen von Einsatzkomponenten für die pharmazeutische Herstellung.
Act as back-up for medical review and assessment and related activities for single cases