Specialist, Manufacturing Quality Assurance

We are looking for a Manufacturing Quality Assurance (MQA) Specialist to join our Quality Assurance team in this role you will play a key part in ensuring GMP-compliant manufacturing operations supporting product quality and maintaining regulatory compliance throughout the product lifecycle. Youll work closely with cross-functional teams while contributing to inspections continuous improvement initiatives and the release of high-quality pharmaceutical products.

Main Responsibilities

• Ensure compliance with relevant legislation GxP regulations and guidelines.
• Perform QA oversight of manufacturing activities including regular shopfloor presence.
• Review and approve batch records specifications SOPs testing methods validation documentation and technology transfer documentation.
• Release or reject raw materials intermediates APIs packaging materials and regenerated solvents based on QC results.
• Prepare and approve release documentation Certificates of Analysis (CoAs) and maintain disposition activities in LIMS/ERP systems.
• Manage and review deviations OOS investigations change controls CAPAs and quality events.
• Support customer audits and regulatory inspections while maintaining inspection readiness.
• Participate in process and cleaning validation new product introductions and continuous improvement activities.
• Act as Deputy Responsible Person for API release when required.

What We Expect

• University degree in Pharmacy Chemistry Biology Chemical Engineering or another relevant Life Sciences discipline.
• Experience in Quality Assurance Quality Control Manufacturing or another GMP-regulated pharmaceutical environment.
• Solid understanding of GMP pharmaceutical quality systems and regulatory requirements.
• Strong quality mindset with excellent attention to detail and the ability to manage documentation-intensive processes.
• Good communication analytical thinking and problem-solving skills.
• Ability to work effectively across cross-functional teams in a dynamic manufacturing environment.
• Fluent English (written and spoken).

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:
Connect with us onLinkedIn