Change Control Manager 70-100% - Rotkreuz, Schweiz - Work Selection

Work Selection

Geprüftes Unternehmen

Rotkreuz, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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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