IT Compliance Specialist

About the Job

Join our team as an IT Compliance Specialist to ensure our systems processes and data handling meet the highest regulatory and security standards. Although your primary focus will be on systems used at the Hungarian sites as part of a global team you will also have an impact on the development of corporate processes procedures and methodologies in a dynamic technology-driven environment.

Main Responsibilities

• Ensure compliance of GxP software systems with applicable regulatory requirements (e.g. FDA 21 CFR Part 11 EU Annex 11 GAMP 5 EU NIS2)
• Participate in procurement development configuration validation and implementation of software applications
• Prepare review and approve Computerized System Validation deliverables including validation plans risk assessments test protocols and reports
• Support periodic reviews changes corrective-preventive actions and re-validation activities for existing systems
• Collaborate with cross-functional teams (QC IT QA Production vendors) to ensure timely project execution and system compliance
• Provide training guidance and technical support to staff on validated software systems
• Contribute to audit readiness by maintaining accurate documentation and supporting regulatory or customer inspections

What We Expect

• Bachelors degree in Life Sciences Computer Science Engineering or a related field
• Fluent in Hungarian and English (spoken and written)
• 4 years of experience in a GxP-regulated environment
• 2 years hands-on CSV experience

Sounds like you

• Strong analytical and data integrityfocused mindset
• Ability to work independently and as part of a team
• Open minded and enjoy continuous learning
• Interested in software solutions and applications

What We Offer

• Competitive compensation and benefit package
• Nordic-style culture dynamic teamwork good working atmosphere flexibility maintaining work-life balance
• Opportunity to learn and develop
• Good team spirit and friendly colleagues
• Stable international company background
• Multinational working environment
• Home office opportunity

Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infectives supplying Active Pharmaceutical Ingredients (APIs) and Finished Dosage Forms (FDFs) to over 500 pharmaceutical companies across 80 countries.

Recognized by the World Health Organization and the European Union for our critical medicines we play a vital role in combating severe infections and antimicrobial resistance. Headquartered in Denmark we operate manufacturing sites in Copenhagen Denmark; Budapest Hungary; and Taizhou China with R&D and commercial operations in seven additional locations globally. As the only European manufacturer of several key anti-infectives and with a heritage spanning over 120 years we are driven by purpose and progress.

With more than 1100 employees our impact starts from within. We offer a workplace where ideas curiosity and initiative thrive and where your role evolves with your ambition. Instead of rigid structures we provide real responsibility freedom to explore and support to grow. Together we shape not only the future of our company and the development of our people but also the health of communities worldwide.

Further information aboutXellia can be found at:
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