Senior Consultant Computer System Validation / ERP Compliance (m/f/d)

As an internal IT service provider, Fresenius Digital Technology supports all business units of the Fresenius Group with innovative and reliable IT services. We strive to find the perfect balance between providing high-quality services and being innovative at the same time. Our investments in state-of-the-art IT will streamline our business processes in the long term and allow us to adapt more flexibly to future changes as part of #FutureFresenius.

In your new role as Senior Consultant Computer System Validation / ERP Compliance (m/f/d) you will take on an important part of the Business Transformation Program to implement SAP S/4HANA. You will be responsible for creating, reviewing and approving of CSV compliance related deliverables and activities which arise from regulatory requirements (e.g. GxP, ICS) within the aforementioned Business Transformation Program.

This position can be filled in Germany or India.

Your assignments

• Part of the FDT initiative to set up a qualified and validated SAP S/4HANA platform, enabling regulated customers to build GxP-compliant business processes

• Part of a project team to consider regulatory requirements (GxP, IT Security, etc.) within new SAP S/4HANA initiative

• Manage suppliers to ensure the personnel is trained and services are delivered in a compliant and timely way in accordance to defined requirements within SAP S/4HANA Program

• Qualification of infrastructure and tooling of newly to-be set up environments, support of project deliverables such as qualification plans, GxP risk assessments, and review of technical specifications

• Validation of platform components of newly to be set up platforms, ensure the delivery of project deliverables such as validation plans, test strategies, and traceability matrices

• Taking on activities to implement and comply with regulatory requirements (GxP, ICS, Data Security, etc.) in existing processes and their continuous improvement

• Enable communication and network with key stakeholder (internal and external) to ensure common agreement to fulfill regulatory requirements and being central contact for resolving issues relating compliance needs

• Providing consultancy and design within area of responsibility for processes and technology

• Responsible for execution and/or monitoring of concept implementation including introduction of operative measures for compliance to regulatory requirements

Your profile

• Degree in natural sciences or economics or equivalent with specialized knowledge in quality management

• At least 5 years of experience in GxP computer system validation (ideally in qualification of IT infrastructure) as well as at least 3 years of experience in SAP (transformation) projects

• Knowledge of regulations and processes, e.g. GxP (EU Annex 11, 21 CFR part 11 etc.), GAMP 5, SOX and ITIL

• Ideally experience with SAP in Cloud installations as well as knowledge of SAP S/4HANA, BTP and ALM

• Experience in the creation, maintenance, handling and application of documents and in conducting training courses and presentations

• Very good conflict resolution, moderation, presentation and communication skills in English, German would be an advantage