Hungary_EU Qualified Person
Core
Lead batch certification and release of biologics products in Hungary, ensuring compliance with EU GMP and EMA requirements while supporting regulatory variations and inspection readiness.
Role type
EU Qualified Person (QP) for biologics
Builds
Certified batches of biosimilar and innovative biopharmaceutical medications
Domain
Biopharmaceuticals / Biosimilars / EU Regulatory Compliance
Required skills
EU GMP compliance, Annex 16 batch release, regulatory variation management, quality system oversight, deviation/CAPA management, MA compliance, sterile manufacturing knowledge
Preferred skills
Deputy QP experience, audit and validation exposure, MIA variation experience, additional EU language proficiency
Technologies
QMS, SMF, CAPA, PQR/APQR
Responsibilities
Lead MIA variation submissions to Hungarian authorities, perform QP certification and batch release, act as contact for regulatory authorities during GMP inspections, manage deviations and change controls, collaborate with global QA and RA teams
Seniority
Mid-level, hands-on IC