EU Qualified Person

Short Description

Partner company provides biosimilar and innovative biopharmaceutical medicines that help improve global access to advanced therapies for patients. The company operates in around 110 countries with more than 30 global partners, focusing on delivering high-quality biologics at affordable prices. We are looking for a new colleague to join their team as EU Qualified Person. 

Description

• Lead and support MIA variation submissions and regulatory updates in Hungary
• Prepare key documentation (QMS, SMF, QP declarations) and support GMP inspection readiness
• Perform EU QP batch certification and release activities in line with Annex 16 requirements
• Review batch documentation and ensure compliance with marketing authorisation requirements
• Oversee quality system processes including deviations, CAPA, and change control
• Participate in PQR/APQR activities
• Collaborate with global and local QA, RA, and manufacturing/CMO partners
• Support product launches and supply continuity

Requirements

• Degree in Biochemistry, Pharmacy, or related field
• Eligibility as EU Qualified Person (QP)
• 2–10 years of experience in pharmaceutical Quality Assurance
• Strong knowledge of EU GMP guidelines, including Annex 1 and Annex 16
• Experience with batch certification, audits, and validation activities
• Experience with MIA variations is an advantage
• Experience in sterile manufacturing is an advantage
• Fluent English is required; Hungarian is preferred, additional EU language is an advantage

Offer

• Competitive salary and annual performance bonus
• Cafeteria, telephone and meal allowance, health insurance, AYCM membership
• Travel support or parking place 
• Opportunity to work in a globally recognized biopharma company
• International, supportive and family-like working environment
• Full-time, permanent contract with immediate start
• Home office possibility

• Budapest