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Product Assurance Expert
4 settimane fa
Per multinazionale farmaceutica, siamo alla ricerca di una figura di:
Product Assurance Expert
La risorsa svolgerà le attività di Product Assurance relativamente alle attività di competenza, al fine di garantire che i processi produttivi vengano costantemente svolti in conformità alle correnti norme di buona fabbricazione (cGMP), ai paramentri di sicurezza (HSE) e alla politica di qualità aziendale.
Mansioni principali:
- Eseguire direttamente e in autonomia, in accordo alle procedure aziendali, le attività di PA relativamente all'area di propria competenza, come:
- Verifica Housekeeping nelle aree produttive al fine di garantire che le aree/fasi produttive siano in compliance con i parametri di sicurezza e con le norme cGMP per i processi produttivi.
- Controllo, revisione e approvazione della documentazione di processo che richiede una verifica di qualità comprensiva dei protocolli, report di validazione e alla stesura degli APRs
- Presenza e supervisione delle aree produttive per investigare e identificare le cause di possibili deviazioni e, supportare il personale di produzione/Quality, per identificare ogni potenziale azione correttiva al fine di migliorare l'efficienza del processo e/o la qualità del prodotto
- Provvedere all'apertura/gestione delle deviazioni, alla loro approvazione e alla stesura della documentazione relativa.
- Eseguire la revisione/approvazione delle procedure operative di controllo (SOPs, BPRs, MBRs, WKI) relativa alle aree Produttive e di Qualità, per garantire che tutti i dati presenti nella documentazione rispettino le cGMP.
- Garantire il corretto flusso della documentazione per le aree produttive (emissione BPRs/MBRs e documentazione di processo di propria competenza) e provvedere alla gestione dei Change Request (inerenti fasi di processo, aree produttive e documentazione) alla loro approvazione ed alla stesura della documentazione relativa.
Requisiti richiesti:
- Laurea scientifica, preferibilmente in: CTF o Biologia
- Preferibile precedente esperienza in ambito QA farmaceutico
- Disponibilità a lavoro su turni, anche notturni
- Buona conoscenza della lingua inglese
Contratto in somministrazione a tempo determinato fino al 15.12.2023
Data inizio prevista: 06/03/2023
Categoria Professionale: Scientifico / Farmaceutico
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Siena (Siena)
Disponibilità oraria:
- Full Time
- Disp. Turni con notte
ATTENZIONE: Abbiamo rilevato la presenza in rete di molti annunci falsi; prendi visione dei nostri consigli per riconoscere i tentativi di truffa al seguente link.
Adecco Italia S.p.A. (Aut. Min. Prot. N.1100-SG del 26.11.2004).
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