Requirements:

• Education and formal qualification requirements
• University degree in informatics, business engineering or equivalent
• Technical background in IT infrastructure
• Expert in Computer System Validation (CSV)
• Required professional skills and experience
• 3-5 years professional experience, working for IT Service Provider
• Practical experience with validation / qualification of GxP-regulated IT Systems and its infrastructure, ideally in QA functions
• Familiar with current GxP regulations in CSV, ideally qualification of IT infrastructure
• Familiar with CSV applications
• Knowledge in ISO 9001 and ISO 20000
• Ideally knowledge in ISO 27001 and ISO 13485
• High customer orientation
• Analytical thinking and structured working methods
• Business fluent English in speaking and writing
• Ideally German language skills
• Mobility - Occasionally traveling in Europe

Job description

Our customer is a German company specializing in comprehensive IT solutions, supporting enterprises in their digital transformation. With extensive experience, it offers high-quality services that include IT infrastructure management, business applications, and modern workplace (Digital Workplace) solutions. The company focuses on long-term relationships, tailoring services to meet clients’ specific needs, ensuring stability, security, and innovation. They operate throughout Germany, with its primary goal being to help clients achieve long-term success in a dynamic technological landscape. The company serves a wide range of clients, including large enterprises and organizations with complex IT needs and provides modern IT infrastructures and scalable cloud solutions, such as SAP and AI, customized to clients’ requirements. Our customer operates as a dynamic IT service provider, supporting the digital transformation of the German economy.

Our customer operates IT Systems for customers from various industries. For specific industries, such as the pharmaceutical industry, specific compliance regulations must be considered during transition / set up of IT systems, its operations until the end of its lifecycle (i.e. GxP-requirements). Within the customer’s organization, a dedicated quality unit is responsible to ensure compliance of customer’s internal processes for IT service operations to the regulatory requirements. The person holding the position described in this document acts as IT Quality Assurance to ensure compliance to the before mentioned regulatory aspects locally. He or she actively works together with the Governance QM-Team to make sure the GxP-relevant processes are implemented, trained and followed locally. The person acts as SPOC and IT Subject Matter expert for all local staff regarding GxP-related activities.

Responsibilities:

• Single Point of Contact for all local GxP-related aspects in collaboration within the Quality Management team
• Execution of local GxP trainings for staff working on GxP-regulated IT Systems / Services. Ensures that all staff working on GxP-regulated IT Systems / Services are trained adequately before execution
• Review of change requests focusing on risk assessments related to GxP-requirements including definition of required documentation
• Consulting of local staff regarding GxP-regulated processes (change management, infrastructure qualification activities, etc.) and tool-based processing.
• Collaboration with QM team to ensure local implementation of GxP-related processes. This includes providing feedback to QM team regarding local issues and proposals for improvement
• Review of validation and qualification documentation processed locally (e.g. IOQ test protocols, screenshots) from quality perspective
• Managing GxP relevant documentation (e.g. training records, process documents, templates)
• Supporting internal and external GxP-Audits as well as CAPA Management