Change Control Manager 70-100% (m/f/d)

For our international medical partner, Roche Diagnostics Int Ltd. based in Rotkreuz, we are looking for a qualified and motivated Change Control Manager for one year with option for extension.

Global External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.

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 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.

Are you interested? Do not hesitate and submit your complete application documents online today.

We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!

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Kontakt
Selina Schumacher

Arbeitsort
Rotkreuz

Pensum
100%

Position
Mitarbeiter

Branche
Pharma + Chemie + Life Science