Change Control Manager

m/f/d, Zug

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.

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.

Contract duration: 12 months

Location: Rotkreuz

Responsibilities:

Managing change execution and change Coordination in the area of Global External Manufacturing with internal stakeholders (e.g. Quality Management) and external contract manufacturers
Responsible for the efficient implementation of changes 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 projects and 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
Fluent German and English
Min. 1-2 years of Project management experience
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

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