Change Control Manager 70-100%

Vor 6 Tagen

Rotkreuz, Schweiz Work Selection Vollzeit

**Beschreibung**:
For our long-standing and well-known business partner, Roche Diagnostics Schweiz AG, based in Rotkreuz, we are looking for a motivated and committed **Change Control Manager** for a temporary assignment of 12 months with the option to extention.

**Tasks**:

- Managing change execution and change Coordination in the area of Global Operations Consumables with internal stakeholders (e.g.
- Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change
- Notification, Design Master Record, Design History File etc.
- Quality Management) and external contract manufacturers
- Responsible for the efficient implementation of changes within Roche and also at the the contract manufacturer
- Planning and implementation of work packages from product care projects with mínimal supervision
- Being a proactive member of the squad
- Identification of process improvements in the working area (e.g. change process)

**Must Haves**:

- First professional experience in document management within a regulated environment
- 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)
- Good knowledge in SAP or comparable ERP system
- Very good communication skills in German and English (spoken and written) are required
- Team player, independent and reliable way of working is expected.

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