The ideal candidate for the Change Control Manager is someone who has previous hands-on experience in change control and experience in GMP regulations and practices.
General Information:
* Start date: to be discussed
* Planned duration: unlimited contract via Hays
* 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 the company 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 user skills in MS Office and Google applications.
* Very good communication skills in German and English (spoken and written) are required.
Deadline for applications 19/02/2025.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Management and Science
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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