EU Qualified Person (QP) – Biologics

About the role

Celltrion Healthcare Hungary Kft., the Hungarian branch of Celltrion Group, which supplies biosimilar and innovative biopharmaceutical products to about 110 countries, is hiring an EU Qualified Person (EU QP) in Budapest. You will work closely with HQ and local QA colleagues on batch certification of biologics, helping establish local QP release capability aligned with EMA requirements and the global supply strategy.

Key responsibilities

• MIA variation and regulatory preparation: lead and support MIA variation and update submissions to the Hungarian authority, prepare documentation (QMS, SMF, QP declaration) and act as subject matter expert during regulatory review
• Inspection readiness and regulatory interaction: lead EU GMP inspection preparation, act as contact for authorities and support CAPA and responses
• Batch certification and release (Annex 16): perform QP certification and batch release, review batch documentation and ensure MA compliance
• Quality system oversight: manage deviations, CAPA and change control, and participate in PQR/APQR
• Cross-functional collaboration: work with global QA, RA and CMOs, and support launches and supply continuity

Required profile

• Degree in Biochemistry, Pharmacy or a related field
• Must meet EU QP eligibility
• 2-10 years of relevant experience in pharmaceutical QA, EU GMP, Annex 1 and Annex 16
• Fluent English; Hungarian preferred; knowledge of another EU language is an advantage
• Preferred: QP / Deputy QP experience, batch certification, audit and validation, MIA variation and sterile manufacturing experience

Required skills

• GMP and GDP knowledge
• Analytical batch certification (Annex 16)

What we offer

• Competitive salary and annual performance bonus
• Cafeteria, telephone and meal allowance, health insurance and AYCM
• Public transport reimbursement or parking in WestEnd
• Full-time indefinite contract starting immediately, with home office possibility