Validation Engineer
1 settimana fa
Pharmapoint, per conto di importante azienda produttrice di API, è alla ricerca di un/una
Validation Engineer
, per il potenziamento della funzione Ingegneria di stabilimento.
La risorsa, con esperienza nella qualifica di apparecchiature, impianti e utilities in ambito GMP, garantirà la corretta gestione ed esecuzione delle azioni atte a garantire piena compliance.
Attività principali:
- Gestione ed esecuzione di FAT, SAT, qualifica iniziale e riqualifiche periodiche
- Esecuzione e coordinamento attività di qualifica con le funzioni interne ed i contractors esterni
- Scrittura e revisione di documenti tecnici come Risk Assessment, DQ-IQ-OQ-PQ, Validation Master Plan e redigere i report di qualifica finali.
- Supporto in ambito change control, CSV, metrologia e audit ispettivi
Requisiti:
- Laurea in Ingegneria (chimica, biomedica), Chimica o CTF
- 2-5 anni di esperienza in ambito engineering/qualification nel settore chimico-farmaceutico
- Ottima conoscenza delle normative cGMP e delle linee guida di settore
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