Equipment Validation Compliance Intern

5 mesi fa

Monza, Italia Thermo Fisher Scientific A tempo pieno

**Work Schedule**

Other

**Environmental Conditions**

Office

Il progetto di tirocinio prevede l'affiancamento al team di Equipment Validation e sarà focalizzato sull'apprendere le procedure e le attività necessarie a garantire che le attività di convalida, calibrazione e manutenzione degli Equipment rispettino le cGMP e gli standard aziendali durante il loro ciclo di vita.

Durante il tirocinio si collaborerà strettamente con il team Change Control, per assicurarsi che ogni change control pianificato alla facility, agli impianti e agli Equipment di sito, che potrebbero influire sulla qualità del prodotto, sia formalmente documentato e che l'impatto sullo stato di qualifica (comprensivo di manutenzione e calibrazione) sia valutato.

Si supporterà il proprio team nel promuovere una partnership aziendale adeguata e proattiva con i Servizi Tecnici (dipartimenti di manutenzione e calibrazione) e i team di ingegneria per garantire che:

- Tutti i documenti generati durante la convalida, la manutenzione e calibrazione siano approvati e autorizzati dal personale appropriato come definito nel sistema di qualità;
- Tutte le attività di convalida, manutenzione e calibrazione siano pianificate e tengano conto del ciclo di vita delle strutture, dell'attrezzatura, degli impianti, dei processi e dei prodotti.
- Tutti le attività previste da nuovi change control siano basate su opportuni razionali e, se necessario, su una valutazione del rischio, e che tutti gli impatti relativi a calibrazione e manutenzione siano correttamente valutati.

REQUISITI:

- laurea di carattere ingegneristico/farmaceutico
- conoscenza dell'inglese e dell'italiano
- ottima competenza nell'uso di MS Office

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