For one of our Clients, a leader in the medical diagnostics field, we are looking for a motivated Change Control Manager.
The perfect candidate is someone who has knowledge and experience in GMP regulations and practices. Furthermore the candidate demonstrates flexibility, adaptability, proactivity and process thinking.
General information:
- Start date: 01.05.2025
- Latest Start Date: 01.06.2025
- Planned duration: 12 months
- Extension: possible
- Workplace: Rotkreuz
- Workload: 70-100%
- Home Office: 1-3 days/week
- Working hours: Standard
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 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)
Must Haves:
- 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.
For one of our Clients, a leader in the medical diagnostics field, we are looking for a motivated Change Control Manager.
The perfect candidate is someone who has knowledge and experience in GMP regulations and practices. Furthermore the candidate demonstrates flexibility, adaptability, proactivity and process thinking.
General information:
- Start date: 01.05.2025
- Latest Start Date: 01.06.2025
- Planned duration: 12 months
- Extension: possible
- Workplace: Rotkreuz
- Workload: 70-100%
- Home Office: 1-3 days/week
- Working hours: Standard
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 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)
Must Haves:
- 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.
