Eu Qualified Person (Eu Qp)

Feladatok: Scope of Responsibilities: MIA Variation & Regulatory Preparation Lead and support MIA variation/update submission to Hungarian authority,Prepare documentation (QMS, SMF, QP declaration),Act as SME during regulatory review,Support GMP inspection readiness.Inspection Readiness & Regulatory Interaction Lead EU GMP inspection preparation,Act as contact for authorities,Support CAPA and responses.Batch Certification & Release (Annex 16) Perform QP certification and batch release,Review batch documentation,Ensure MA compliance.Quality System Oversight Manage deviation, CAPA, change control,Participate in PQR/APQR.Cross-functional Collaboration Collaborate with global QA, RA, CMOs,Support launch and supply continuity.Gyógyszerész; Minőségbiztosítás; Törzskönyvezés

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