Head of Quality
2 settimane fa
La tua nuova azienda
Azienda farmaceutica italiana di medie dimensioni orientata alla valorizzazione di prodotti maturi.
Il tuo nuovo ruolo
Il ruolo di Head of Quality prevede la supervisione di un team di lavoro ad oggi composto da due risorse e con le seguenti responsabilità:
Gestione dei processi di Technology Transfer
Gestione e aggiornamento di un Dossier chimico-farmaceutico
Stesura e aggiornamento Quality Agreement
Gestione e valutazione indicatori di qualità (Product Quality Review)
Monitoraggio documenti di produzione dei fornitori e di rilascio dei lotti
Master Batch Record Review
Audit e gestione CAPA Plan
Quality risk management di prodotto
Gestione Change Control
Gestione Reclami e Richiami prodotto
Valutazione e qualificazione di nuovi fornitori di prodotti e servizi influenti sulla qualità del prodotto
Controlli di qualità GDP lungo la filiera
Stesura ed aggiornamento procedure operative
Comunicazioni e informazioni di Farmacovigilanza per la qualità
Supporto al dipartimento RA per le richieste delle autorità regolatorie
Gestione Sistema Qualità ISO 9001
- Gestione piani formazione e training
Di cosa hai bisogno per aver successo
Il/la candidato/a ideale ha un background di studi scientifico e consolidata esperienza nel ruolo in aziende di produzione farmaceutiche.
La risorsa ha esperienza nelle attività delineate, nella gestione di un team di lavoro e buona capacità di relazionarsi con interlocutori interni ed esterni.
Buona conoscenza della lingua inglese.
Si offre contratto a tempo indeterminato CCNL Chimico Farmaceutico.
Luogo di lavoro: Milano
I candidati di ambo i sessi, dopo aver visionato l'informativa obbligatoria sulla privacy sul sito , sono pregati di inviare il CV in formato Word, indicando il riferimento (Rif nonché il proprio consenso al trattamento dei dati personali ex D.LGS. 196/03. Aut. Min. N. 13/I/0007145/03.04 del 1 Aprile 2008
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