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Die Celltrion Group bietet Biosimilars und innovative biopharmazeutische Medikamente an, um Patienten weltweit den Zugang zu fortschrittlichen Therapien zu erleichtern. Die Celltrion Group bietet Biologika in rund 110 Ländern an und arbeitet mit mehr als 30 globalen Partnern zusammen. Mit praktischer Erfahrung und Wissen, das in jahrelanger Arbeit in den fortschrittlichen Pharmamärkten weltweit gesammelt wurde, hat die Celltrion Group Vertriebskanäle gesichert und versorgt Patienten mit Biosimilars zu erschwinglichen Preisen. About Us: Celltrion Inc is a world leader in biologic therapeutics, offering high quality biosimilar products in nearly 110 countries with the aim of advancing the well-being of humanity ever since 2002. The Hungarian branch, Celltrion Healthcare Hungary Kft. has been established in 2012 and since then we have been growing steadily. Our office is in the center of Budapest, in WestEnd Office Towers. We are opening a brand-new position for an EU Qualified Person (EU QP). Join Early. Make an Impact. Grow With Us. This position offers the opportunity to contribute from the ground up as a key individual expert within a growing team. You will work closely with both our HQ and local QA colleagues, playing a pivotal role in supporting the establishment and operation of batch certification activities for biologics products in Hungary. Additionally, this role will contribute further to enabling local QP release capability aligned with EMA requirements and global supply strategy. Scope of Responsibilities: MIA Variation & Regulatory Preparation • Lead and support MIA variation/update submission to Hungarian authority, • Prepare documentation (QMS, SMF, QP declaration), • Act as SME during regulatory review, • Support GMP inspection readiness. Inspection Readiness & Regulatory Interaction • Lead EU GMP inspection preparation, • Act as contact for authorities, • Support CAPA and responses. Batch Certification & Release (Annex 16) • Perform QP certification and batch release, • Review batch documentation, • Ensure MA compliance. Quality System Oversight • Manage deviation, CAPA, change control, • Participate in PQR/APQR. Cross-functional Collaboration • Collaborate with global QA, RA, CMOs, • Support launch and supply continuity. Requirements: • A degree in Biochemistry, Pharmacy, or a related field, • Must meet EU QP eligibility, • 2–10 years relevant experience in pharmaceutical QA, • EU GMP, Annex 1, Annex 16 experience, • GMP, GDP knowledge, • Languages: fluent English required; Hungarian preferred; knowledge of an additional EU language is an advantage. Preferred Background: • QP / Deputy QP experience, • Batch certification experience, • Audit and validation exposure, • MIA variation experience preferred, • Sterile manufacturing experience preferred. What we offer: • Competitive salary and annual performance bonus, • Cafeteria, telephone and meal allowance, health insurance, AYCM, • Local public transportation reimbursement or parking place in Westend, • Opportunity to work in a globally recognized biopharma company, • International company, family atmosphere, • Dynamic and supportive work environment, • Full-time, Indefinite contract (starting immediately), • Home office possibility. Apply with your CV in English