Change Control Manager - Engineering/Change Management/GxP/Project Management
Project Background:
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.
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 Roche and also at 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:
* 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
* First professional experience in document management within a regulated environment
* Good knowledge in SAP or comparable ERP system
Languages:
* German fluent (C1 / C2 Level)
* English fluent (C1 / C2 Level)
Reference Nr.: 924019FC
Role: Change Control Manager
Industry: Pharma
Work Location: Rotkreuz
Workload: 70 - 100%
Start: 01.05.2025
Dauer: 12 Monate
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
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