Consultant Computer System Validation (m/f/d)

We are the Quality & System Compliance team at Fresenius Digital Technology and are part of IT Finance. What are we about? Compliance with Fresenius' high quality standards in the highly regulated healthcare sector - in the context of increasing globalization and the associated standardized IT environments. Our quality policy is not only focused on products and services, but also on our customers, employees, processes and our business success. It is therefore clear that the integration of GMP regulations into our quality management system plays an important role. Our topics: Audit and Quality Management, Computer System Validation, IT Infrastructure Qualification, IT Change and Problem Management and IT Compliance.

As a Consultant Computer System Validation (m/f/d) you will support and advise our specialist departments on regulatory compliance issues and realize strategies for the implementation of legal requirements. You will ensure compliance with regulatory requirements in existing processes and ensure their continuous improvement.

Is that exactly your thing? Then become part of our team!

Your tasks

• Developing validation and qualification concepts taking into account customer requests and legal requirements in preparation for the creation of validation and qualification (master) plans

• Competent, timely and cost-effective handling of projects in the areas of computer system validation (CSV) and qualification of IT infrastructure

• This project work includes the creation and quality assurance of project content, such as the creation of risk analyses, review of technical specifications and test strategies as well as the creation of traceability matrices

• Collaboration with project members to ensure validation and qualification activities in an international environment

• Supporting data migration projects

• Supporting activities for IT supplier qualification (e.g. audit)

• Planning and implementation of trainings for your own department

Your profile

• Degree in natural sciences or economics or a comparable field of study

• At least 3 years of experience in the field of computer system validation

• Good specialist knowledge in quality management

• IT affinity and ideally good knowledge of SAP and ServiceNow

• Sound knowledge of regulations and processes (GMP, FDA, SOX, ITIL)

• Experience in the creation, maintenance, handling and application of documents

• Experience in conducting training courses and presentations

• Very good communication, facilitation and presentation skills in fluent English and German

• Strong problem solving skills and quality awareness