Lavori attuali relativi a Quality Assurance and Regulatory Affairs Specialist - Milano, Lombardia - Confidenziale
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Quality Assurance and Regulatory Affairs Specialist
3 mesi fa
QUALITY ASSURANCE AND REGULATORY AFFAIRS SPECIALIST
- Gestione del sistema qualità secondo gli standard ISO 13485;
- Gestione della stesura e revisione della documentazione del Sistema Qualità:
Manuale, Procedure, Moduli;
- Sviluppo delle schede tecniche di prodotto per l'approvazione MDR;
- Gestione, in collaborazione con QA, delle non conformità dei prodotti acquistati, provvedendo \'eventuale restituzione al fornitore dei prodotti finiti non conformi;
- Preparazione, verifica ed archiviazione delle dichiarazioni di Conformità e mantenimento di tutta la documentazione di controllo;
- Effettuazione di controlli dei prodotti assemblati|confezionati e di controlli in accettazione sui prodotti finiti in magazzino, in accordo alle istruzioni di controllo interne;
- Mantenimento e sviluppo della validazione bibliográfica clinica e della documentazione di gestione del rischio;
- Gestione, in collaborazione con QA, dell\'inserimento e dell\'aggiornamento dei dati aziendali sulla banca dati europea sui dispositivi
medici;
- Revisione dei cataloghi aziendali, delle schede tecniche dei prodotti e del labelling dei prodotti;
- Controllo delle attività di supervisione e post-marketing;
- Gestione delle attività di validazione dei processi sterilizzazione, confezionamento, clean room;
- Partecipazione ad audit fornitori e clienti e rapporto con gli stessi;
- Interazione con le autorità regolatorie nazionali ed internazionali.
Si prendono in considerazione sia persone entro i 5 anni di esperienza sia Neolaureati in materie Scientifiche.
Contratto da definirsi in funzione \'esperienza pregressa.
lavoro:
Mantovbr>
01|12|
Categoria Professionale:
Scientifico | Farmaceutico
Città:
Mantova Mantova
Patenti:
B
Disponibilità oraria:
Full Time
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