Hungary_eu Qualified Person

Celltrion Healthcare

Budapest, Hungary
Competitive salary; annual performance bonus; cafe...
Hybrid (home office possibility)
Eu qualified person eligibility
Batch certification under annex 16
Eu gmp and gdp knowledge
Celltrion Healthcare is seeking an EU Qualified Person (QP) for its Budapest office, focusing on supporting batch certification activities for biologics products. The ideal candidate should possess relevant experience in pharmaceutical quality assurance and compliance with EU GMP regulations

Job Summary

  • This role offers the opportunity to contribute from the ground up as a key individual expert within a growing team at Celltrion Healthcare Hungary.
  • The successful candidate will perform QP certification and batch release while ensuring compliance with MA requirements and EMA regulations.
  • Benefits include a competitive salary, annual performance bonus, health insurance, and the possibility of working from home.

Matching Summary

Match Score: 85

Celltrion Healthcare is seeking an EU Qualified Person (QP) for its Budapest office, focusing on supporting batch certification activities for biologics products. The ideal candidate should possess relevant experience in pharmaceutical quality assurance and compliance with EU GMP regulations.

Salary

Competitive salary; Annual performance bonus; Cafeteria, telephone, meal allowance, health insurance, AYCM, transport reimbursement

Skills & Requirements

Must-have

  • EU Qualified Person eligibility
  • Batch certification under Annex 16
  • EU GMP and GDP knowledge
  • MIA variation submission experience
  • Fluent English language skills

Nice-to-have

  • Hungarian language proficiency
  • Sterile manufacturing background
  • Audit and validation exposure
  • Deputy QP experience
  • Cross-functional collaboration skills

Key Requirements

  • Degree in Biochemistry, Pharmacy, or related field
  • 2–10 years relevant pharmaceutical QA experience
  • Must meet EU QP eligibility criteria
  • Fluent English required; Hungarian preferred

Work Rights

Not specified

Tailored Resume

Cover Letter