Quality Assurance Deviation Specialist
2 settimane fa
FILIALE: BERGAMOSPECIALIZZAZIONE: Life Science
La nostra azienda, Gi Group Spa Filiale Di Bergamo Cefalonia, è una nota multinazionale operante nel settore della logistica con Divisione Healthcare in forte sviluppo e focalizzata su attività di stoccaggio, confezionamento e distribuzione di farmaci e dispositivi medici per importanti aziende di settore, tra le prime al mondo.
Siamo alla ricerca di un/a:
Quality Assurance – Deviation & CAPALa risorsa, che risponderà alla Quality Manager, avrà l'opportunità di cooperare con il team italiano ed internazionale per la gestione di progetti in ambito logistico farmaceutico e bio-medicale. Gli obiettivi principali sono:
- Assicurare che le attività operative legate alla produzione siano eseguite nel rispetto dei requisiti delle GMP, dei requisiti normativi e degli standard di qualità aziendali;
- Attività di controllo di Qualità nelle tempistiche concordate con i clienti;
- Garantire che le attività di produzione siano eseguite entro le tempistiche pianificate;
- Verificare la correttezza dei documenti di produzione (Batch Record review);
- Garantire la corretta gestione dei contro campioni;
- Garantire la corretta gestione delle deviazioni che si verificano durante le attività di produzione e successivo follow up sulle azioni correttive;
- Collaborazione con la Qualified Person nella definizione dei KPI legati alle attività di produzione e attività di controllo qualità;
- Elaborare report e trend relativi alle attività di produzione;
- Creati ondi aggiornamento delle procedure operative legate ai processi produttivi;
- Product quality review;
- Preparare audit interne ed esterne GMP;
- Attività di qualifica e convalida di strumenti legati alla produzione;
- Supporto al dipartimento di Qualità nella definizione delle azioni da intraprendere a seguito di aggiornamenti delle GMP e delle normative applicabili;
- Supporto nella gestione dei processi operativi aziendali con impatto QA;
- Supporto nel garantire un miglioramento continuo del Sistema di Gestione di Qualità.
Requisiti:
- Laurea in ambito scientifico;
- Esperienza di 6 mesi/1 anno nella mansione in aziende farmaceutiche, chimiche o cosmetiche;
- Ottima conoscenza delle GDP;
- Inglese B1/B2;
- Ottime capacità comunicative;
- Capacità di lavorare in team.
Risultato contrattuale:
- Contratto diretto con azienda a tempo determinato di 12 mesi, finalizzato all'assunzione a tempo indeterminato;
- RAL da definire in fase di selezione;
- Ambiente lavorativo stimolante, giovane, informale e flessibile;
- Training per soft e hard skills;
- I valori che ci contraddistinguono: attenzione, collaborazione, passione, sostenibilità, apprendimento continuo e innovazione, responsabilità.
Paga stimata: €40.000-€60.000 all'anno.
Nel rispetto del D.lgs. n. 198/2006 e ss.mm.ii., e dei Decreti Legislativi n. 215 e n. 216 del 2003 sulle parità di trattamento, si invitano tutti i candidati interessati a candidarsi per questo ruolo.
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