Computer System Validation Specialist

3 settimane fa

Pescara, Italia GIGROUP A tempo pieno

Il nostro cliente è una nota azienda biofarmaceutica italiana con una pipeline di farmaci di sintesi e biotech, presente sul territorio nazionale con Ricerca &
Sviluppo, Produzione e Rete commerciale.
Offriamo un’interessante opportunità come
CSV Specialist

Il profilo selezionato sarà inserito all’interno del team CSV e si occuperà principalmente di:

- Supportare la revisione della progettazione e della documentazione técnica di sistema in relazione ai progetti informatici corporate e di plant con impatto GxP.
- Garantire l’esecuzione e/o il coordinamento di attività di validazione e di revisioni periodiche di sistemi computerizzati e infrastruttura IT/OT (e.G., definizione dell’approccio di convalida del progetto, redazione e/o verifica della documentazione connessa, ecc.).
- Supportare i reparti coinvolti in processi GxP relativamente ad aspetti di digitalizzazione.
- Effettuare la valutazione e supporta la definizione di Risk Assessment a fronte dell’implementazione di progetti e/o a seguito di deviazioni connesse all’ambito tecnologico-informatico con impatto GxP.
- Gestire e/o supportare la gestione degli eventi di qualità assegnati (e.G., change control, CR SAP, CR automazione, deviazioni, CAPA);
- Redigere e revisionare le SOPs di ambito CSV / informatico con impatto GxP
- Supportare la conduzione di audit interni (Data Integrity)
- Supportare l’esecuzione della qualifica dei fornitori di servizi IT e nella definizione dei relativi QTAs
- Esercitare l’attività di System Administrator dei sistemi connessi alla strumentazione di laboratorio del Controllo Qualità e sistemi gestionali
- Agire da Subject Matter Expert per l’area CSV/IT compliance nel corso di ispezioni da parte delle autorità regolatorie.

**Requisiti richiesti**:
Laurea in Ingegneria Biomedica o Chimica, Scienze Informatiche, CTF o titoli di studio equiparabili.
Minimo 1 anno di esperienza consolidata in ambito CSV / Data Integrity / IT Compliance.

**Offerta Contrattuale**:
Contratto a Tempo Indeterminato, livello e retribuzione da valutare in sede di colloquio.

**Sede di lavoro**:
L’Aquila

**I valori che ci contraddistinguono**:
Gi Group S.P.A. è autorizzata ad operare dal Ministero del Lavoro (Aut. Min. 26/11/2004 PROT. 1101 - SG).

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