Get AI-powered advice on this job and more exclusive features.
Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting.
For our client Roche Diagnostics in Rotkreuz, we are looking for a reliable Change Control Manager.
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.
General Information:
• Remote/Home Office: 1-3 days a week
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.
* 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 communication skills in German and English (spoken and written) are required.
Are you interested? We are looking forward to receiving your application!
Seniority level
Associate
Employment type
Contract
Job function
Other
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
#J-18808-Ljbffr