Qa Computer System Validation

2 giorni fa

EmiliaRomagna, Italia Buscojobs A tempo pieno

Adecco LifeScience, divisione specializzata di AdeccoItalia S.P.A., è alla ricerca di un QA Computer System Validation (CSV) da inserire all'interno della divisione Healthcare di una realtà che si occupa di attività di stoccaggio, confezionamento e distribuzione di farmaci e dispositivi medici.

Principali attività:

  • Pianificherai, eseguirai e gestirai le attività di convalida di sistemi computerizzati (CSV) in conformità con le normative GxP;
  • Svilupperai e manterrai la documentazione di convalida, tra cui piani di convalida, protocolli di test (IQ, OQ, PQ), report di convalida e altre documentazioni correlate;
  • Garantirai che tutti i sistemi e le applicazioni siano convalidati prima della messa in produzione e che vengano mantenuti conformi durante il loro ciclo di vita;
  • Implementerai le procedure e i controlli definiti dal reparto CVS internazionale;
  • Collaborerai con i team di QA e Technical Department per identificare e mitigare i rischi associati ai sistemi computerizzati;
  • Parteciperai ad audit interne ed esterne relative ai sistemi computerizzati;
  • Gestirai i progetti di validazione di sistemi computerizzati;
  • Revisionerai e seguirai il consolidamento dei Change Control;
  • Gestirai e documenterai le modifiche ai sistemi computerizzati e ti assicurerai che le modifiche siano valutate e convalidate correttamente;
  • Supporterai il Change Control per garantire che tutte le modifiche ai sistemi siano gestite in conformità con le normative vigenti;
  • Fornirai formazione e supporto ai dipendenti in merito alle best practice di convalida dei sistemi computerizzati;
  • Supporterai la risoluzione di problemi relativi ai sistemi convalidati.

Requisiti:

  • Laurea in Biotecnologie, Chimica Farmaceutica, Biologia o discipline scientifiche (eventuali lauree di primo livello da valutare in base all'esperienza);
  • Esperienza pregressa in ambito CSV, preferibilmente nel campo farmaceutico (almeno 1 anno);
  • Conoscenza approfondita delle normative GxP, delle linee guida FDA / EMA e delle best practice GAMP;
  • Esperienza nella redazione di documentazione di convalida e nella conduzione di test di convalida (IQ, OQ, PQ);

Orario di lavoro:

Lun - Ven 8.30 - 17.30

Sede di lavoro:

Calcinate (BG)

Inquadramento:

Contratto direttamente con l'azienda a tempo determinato iniziale finalizzato al tempo indeterminato.

Lingue conosciute:

Inglese: Comprensione Buono

Disponibilità oraria:

Full Time

Patente:

B

Mezzo di trasporto:

Auto

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