Hungary_EU Qualified Person
Core
Lead batch certification and release of biologics products in Hungary, ensuring compliance with EU regulations and supporting regulatory submissions.
Role type
EU Qualified Person (QP) for biologics
Builds
Certified batches of biosimilar and innovative biopharmaceutical medications
Domain
Biopharmaceuticals / Biosimilars / EU Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EU QP eligibility, Batch certification, Regulatory submission preparation, GMP inspection readiness, Quality system management, MA compliance
Preferred skills
Deputy QP experience, Sterile manufacturing experience, MIA variation experience, Audit and validation exposure
Technologies
EU GMP, Annex 1, Annex 16, QMS, SMF
Responsibilities
Lead and support MIA variation submissions to Hungarian authorities, Perform QP certification and batch release, Lead EU GMP inspection preparation, Manage deviation and CAPA processes, Act as contact for regulatory authorities, Collaborate with global QA and RA teams
Seniority
Mid-level, hands-on IC
