Bei Daiichi Sankyo stehen wir vereint hinter einem einzigen Ziel: Das Leben auf der ganzen Welt durch innovative Medikamente zu verbessern. Mit aktiver Innovation seit 1899, Präsenz in mehr als 30 Ländern und über 19.000 Mitarbeitern entwickeln wir bahnbrechende Therapien in der Onkologie, für Herz-Kreislauf-Erkrankungen, seltene Krankheiten und Immunerkrankungen. Im Einklang mit unserer Vision 2030, "ein innovatives globales Gesundheitsunternehmen zu sein, das zur nachhaltigen Entwicklung der Gesellschaft beiträgt", gestalten wir eine gesündere, hoffnungsvollere Zukunft für Patienten, ihre Familien und die Gesellschaft.
For our Daiichi Sankyo Europe GmbH headquarters in Munich we are currently seeking highly qualified candidates to fill the position:
Expert (m/w/d) Quality Systems
Roles and Responsibilities:
- Serve as Regional Administrator for electronic quality management tools like document management system and training management system
- Perform first level support for all users of Regional electronic quality management tools
- Support Regional Process Leads und Process Owners in continuous monitoring of process performance and process optimization projects
- Deputy Regional Process Leads and Process Owners in Regional meetings and projects
- Support implementation of best practice standards and ensure compliance with quality and regulatory requirements
- Support document and training material creation
- Support migration and testing activities for computerized systems
Personal skills and professional experience:
- Completed studies in natural sciences / pharmaceutical sciences or a comparable qualification
- 2+ years of relevant professional experience in a GMP/GDP-regulated environment
- Experience with electronic quality management systems in GMP/GDP environments (e.g. Veeva Vault, TrackWise Digital, Compliance Wire, SAP S4)
- Experience with user acceptance testing for computer system validation is a plus
- Excellent communication skills
- Strong attention to detail and highly focussed on a right-first-time concept
- Good knowledge of relevant regulations from various authorities (e.g., EMA, SwissMedic, MHRA, Health Canada, etc.)
- Excellent German and English skills, both written and spoken
