Quality Assurance Associate
4 giorni fa
**Proponiamo un’interessante opportunità come**:
Quality Assurance Associate
L’azienda nostra cliente è una società farmaceutica italiana specializzata nella ricerca, sviluppo e commercializzazione a livello globale di Farmaci, Dispositivi Medici e Nutraceutici, nelle aree pediatria, oculistica, gastroenterologia, allergologia, ginecologia, oncologia e sistema nervoso centrale.
**Le principali attività saranno**:
Preparazione e aggiornamento delle procedure e dei documenti del Sistema di Qualità aziendale in compliance con i requisiti GMP, GDP, ISO13485 e MDR 2017/745
Revisione della documentazione di rilascio di prodotti farmaceutici e principi attivi
Preparazione della documentazione di non-conformità, reclami, CAPA, change control e aggiornamento dei relativi database di prodotti farmaceutici, Food Supplements e Medical Devices
Gestione delle richieste di documentazione da parte dei clienti e dei fornitori
Esecuzione della qualifica periodica dei fornitori di prodotti farmaceutici, Food Supplements e Medical Devices
Partecipazione alle self-inspection e agli audit effettuati da clienti, Health Authorities e Organismi Notificati
Collaborazione con la Supply Chain nelle relazioni con i partners commerciali
Monitoraggio rispetto degli indicatori relativi alle GDP per ciò che concerne il magazzino
Il profilo ricercato possiede una laurea scientifica e almeno 1 anno di esperienza nella produzione di prodotti farmaceutici e Medical Devices, preferibilmente in ambito Quality Assurance o Regolatorio. È richiesta la conoscenza delle normative GMP, GDP, ISO13485 e MDR 2017/745 e una conoscenza fluente della lingua inglese.
**Offerta Contrattuale**: Contratto a Tempo indeterminato, livello e retribuzione da valutare in sede di colloquio.
**Sede di lavoro**: Milano città.
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