Change Control Manager 70-100% (m/f/d)
Work Selection
- Rotkreuz, Zug
- Befristet
- Vollzeit
- Managing change execution and change Coordination in the area of Global Operations Consumables with internal stakeholders (e.g.
- Quality Management) and external contract manufacturers
- Responsible for the efficient implementation of changes within Roche and also at the the contract manufacturer
- Responsible for compliance application of the change and the corresponding KPIs
- Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change
- Notification, Design Master Record, Design History File etc
- Planning and implementation of work packages from product care projects with minimal supervision
- Being a proactive member of the squad
- Identification of process improvements in the working area (e.g. change process)
- B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
- Work experience in change management or in project and process management
- Practical experience in a regulated GxP environment, ideally in medical devices/IVD industry (ISO 13485, FDA 21 CFR 820, IVDR/MDR)
- First professional experience in document management within a regulated environment
- Good knowledge in SAP or comparable ERP system
- Very good user skills in MS Office and Google applications
- Very good communication skills in German and English (spoken and written) are required
- Team player, independent and reliable way of working is expected.