Change Control Manager

vor 1 Woche


Rotkreuz, Zug, Schweiz Flexsis Vollzeit
**INTRODUCTION: **Change Control Manager

General Information:

Start date:

Latest Start Date:
Planned duration: 1 year

Extension:
likely

Workplace:
Rotkreuz

Workload: 70-100%

Remote/Home Office: 2-3 days a week

Travel:
less than 5%

**ASSIGNMENT DESCRIPTION:
**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 client 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
  • Identification of process improvements in the working area (e.g. change process)
**REQUIRED PROFILE:
**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


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