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Change Control Manager
vor 3 Monaten
Change Control Manager (GxP environment)
For our client, one of the worlds largest biotech companies, we are currently looking for a qualified **Change Control Manager **(GxP environment)
**General Information**:
- Start date: asap
- latest Start Date: 01.04.2024
- Workload: 70-100%
- Home Office: 2-3 days a week
**Tasks & Responsibilities**:
- 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 the company 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** an**d English** (spoken and written) are required
- Team player, independent and reliable way of working is expected
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