Change Control Manager 70-100%

vor 1 Tag

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.

Global Operations Consumables is the competence center for single-use injection molded parts in the diagnostic workflow. This includes the development of new consumables, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement. It has expertise in all injection molding and plastic-relevant areas: Mold technology, polymers, automation, product design, supplier management, injection molding technique, plastics technology and material sciences.

**Tasks**:

- 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 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 mínimal supervision
- Being a proactive member of the squad
- Identification of process improvements in the working area (e.g. change process)

**Must Haves**:

- 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 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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