Quality Unit Director - Roma - Recipharm

    Recipharm
    Recipharm Roma

    14 ore fa

    Descrizione

    Per conto dello stabilimento di Brescia del Gruppo Recipharm, produttore di antibiotici sterili betalattamici, siamo alla ricerca di un/unaQuality Unit Director & QPLa risorsa avrà la responsabilità di garantire un Sistema di Qualità adeguato ed efficiente, in termini di processi, procedure e controllo analitico, assicurando il costante allineamento con le funzioni aziendali e il pieno rispetto delle GMP e delle normative vigenti.Il ruolo prevede la guida della Quality Unit di stabilimento e l'assunzione delle responsabilità di Persona Qualificata (QP).Principali responsabilità: Garantire la piena compliance alle GMP e ai requisiti regolatori, assicurando un Sistema di Qualità solido, efficace e costantemente allineato agli standard aziendali e corporateCoordinare la Quality Unit e supervisionare le attività di laboratorio, nel rispetto di tempistiche, volumi e standard qualitativiAssicurare, in qualità di QP, il rilascio dei lotti di produzione, attestandone la conformità a dossier registrativi e autorizzazioni all'immissione in commercioPresidiare la gestione di deviazioni, non conformità, reclami, CAPA e Change Control, garantendo analisi strutturate e implementazione efficace delle azioni correttiveGuidare audit interni ed esterni e partecipare attivamente alle ispezioni delle Autorità Regolatorie e dei clientiCollaborare con Produzione e funzioni tecniche per l'introduzione di nuovi prodotti e il miglioramento continuo dei processi in ambito sterileMonitorare KPI di qualità e promuovere una cultura orientata alla compliance, alla performance e alla responsabilitàRequisiti: Laurea in discipline scientifiche.Nomina AIFA come Persona Qualificata.Esperienza consolidata in aziende farmaceutiche con produzioni sterili.Esperienza nella gestione di team Quality e nell'interazione con Autorità regolatorie.Buona conoscenza della lingua inglese. xivgfpx Nel processo di selezione, Pharma Point si impegna a garantire pari opportunità a tutti i candidati, indipendentemente da genere, età, orientamento sessuale, origine etnica, nazionalità, disabilità o appartenenza sindacale.


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