IT Quality Assurance Officer

You may not know our name but we can guarantee you know our work – all we do has a positive impact on life, health and the environment. Eurofins is by your side every day from the food you eat to the medicines you rely on. We work with the biggest companies in the world, making sure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialized clinical diagnostics testing. With over EUR 4.5 billion in annual revenues and over 50,000 employees in around 800 laboratories in 50 countries, Eurofins Scientific is a leading international group of laboratories providing a unique range of analytical testing services to the pharmaceutical, food, environmental and consumer products industries and to governments. With facilities in Europe, the United States and Asia, Eurofins Genomics is an internationally leading provider of DNA sequencing services, genotyping services, DNA synthesis products and bioinformatics services for pharma, diagnostics, food, agriculture, biotechnological and research markets.

Do you have a compliance mindset and a strong background in IT and science? Do you enjoy collaborating with international teams?

We are looking for an IT Quality Assurance Officer to join a challenging and unique large-scale Transformation Program with high impact and visibility.

The IT Quality Assurance & Compliance Officer is part of the Regional IT Governance team and is responsible for ensuring the effectiveness of IT Qualification and Validation Processes (in scope of IT Solutions, Infrastructure and Security) across the Region. The IT Quality Assurance & Compliance Officer is also responsible for establishing the Infrastructure Qualification Framework and Supporting Processes, aligned with GxP requirements from supported Business Zones.

This role requires experience in “GAMP Infrastructure Control and Compliance” and GxP guidelines and regulations.

Conceive, Own, Ensure the implementation of the IT Infra Qualification Framework

• Accountable for the development and implementation of Quality Programs in accordance with GxP practices;
• Establish a Qualification Master Plan by collaborating with SMEs from IT Infrastructure, IT Security, Project Management and Quality Assurance (business);
• Ensure that relevant IT Team members are trained on IT Qualification/Validation, as per GxP/GAMP fundamentals;
• Support the IT Infrastructure teams to create, revise and endorse the documentation set (i.e. policies, procedures and protocols) used to establish or maintain compliance of computerized systems;
• Collaborate with Eurofins businesses and IT infrastructure teams to define technical and business requirements associated with the lifecycle of IT systems;
• Translate requirements, concepts and ideas into detailed, tangible documents, diagrams, charts, and other written or visual media;
• Identify and implement continuous improvement initiatives.

Drive and Govern IT Infrastructure Qualification efforts

• Ensure IT Infrastructure Qualifications and Maintenance in agreement with ‘GAMP Infrastructure Control and Compliance‘;
• Support the IT Infrastructure teams to carry out the Qualification/Testing Activities and to generate reports;
• Coach / Oversee the IT Infrastructure teams to maintain IT Infrastructure (and its documentation) in Qualified state once in operation;
• Assist User Zones with Qualification Documentation required for regulatory/customer Audits;
• Support/Audit IT Infrastructure Support Teams to ensure compliance of their operations to GxP and other applicable regulatory standards.

Risk Management

• Create/Collaborate on IT Risk Management Process/documents in alignment with industry standards;
• Work with Global IT Risk and Compliance Team for smooth implementation of relevant process within Zones;

Support with Software Validation efforts

• Help Zone IT Solution Teams to ensure compliance of their IT Services (Solutions) with GxP and other applicable regulatory standards;
• Provide Support/Training for implementing Eurofins Computerized Systems Validation Framework (ECSVF) for IT Applications;

Are you our kind of extraordinary?

You will have a Scientific or Technical Degree and 3 to 7 years in a similar position.

You have experience with GAMPmodel and GxPregulated organization (preferably within an IT environment) and have experience in IT Application Validation and IT Infrastructure Qualification.

We are looking for team players fluent in English, with excellent communication skills and system thinking (big picture thinkers), who would be able to work under minimal supervision.

The role can also be based in:

• Leiden, the Netherlands
• Milan, Italy
• Barcelona, Spain

What can we offer you?

• A multicultural, friendly and collaborative work environment in a fast-growing international company
• Opportunities for growth and take that next step in your professional career and self-development
• Long-term engagement and career development