Computer System Validation

3 giorni fa

Aprilia, Italia Fortil A tempo pieno

**FORTIL** è una società di engineering consulting creata da ingegneri con mentalità imprenditoriale. Il nostro modello, nato nel 2009, si basa non solo su eccellenza e precisione, ma anche su condizioni di condivisione in continua evoluzione. Il 100% delle azioni del gruppo appartengono ai nostri dipendenti, i quali sono guidati verso l'azionariato, in un percorso definito da livelli di impegno e dal contributo di valore aggiunto per il gruppo. Il nostro intento è di portare al 30% la quota dei nostri dipendenti associati.

Ad oggi siamo 2000 dipendenti, distribuiti in 13 paesi, ciò che ci caratterizza è l’interesse per la sostenibilità, un alto livello di competenza, un'organizzazione agile e una forte azione sociale.

**Il nostro obiettivo**:diventare il più grande gruppo indipendente di ingegneria in Europa al servizio delle generazioni future.**

Lavorando con noi entrerai in contatto con un team giovane e ambizioso, in un contesto multiculturale e internazionale

Stiamo cercando un Computer System Validation - Pharma (CSV)

**IL TUO RUOLO**:

- Redazione, verifica ed esecuzione di protocolli e test di qualifica di impianti generali (Systems, utilities) e di processo (equipment), effettuazione DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification) e PQ (Performance Qualification)
- Redazione di validation plan
- Redazione URS, VMP, VP, GMP review e Risk assesment
- Redazione ed esecuzione di protocolli di CIOQ (Compliance con 21 CFR PART 11, ANNEX 11)
- Redazione ed esecuzione protocolli di monitoring
- Redazione di validation report
- Uso di sistemi computerizzati (LAS, PCS, MES)

**IL TUO PROFILO**:

- Esperienza pregressa nel ruolo di 1/2 anni
- Sede di lavoro Provincia di Udine

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