Quality Assurance Engineer (Batch Record And Change Control)
Cai
In questo ruolo, supporti la gestione e la revisione dei Master Batch Record e accompagni la transizione da cartaceo a electronic Batch Record (eBR) nel contesto GMP. Lavori in stretta collaborazione con funzioni interne come Produzione, QA, Engineering e Validation per garantire la conformità e l’aggiornamento della documentazione di produzione. Contribuisci al controllo delle Change Control, assicurando follow-up e tracciabilità. L’opportunità ti permette di crescere in un ambiente specialistico, con focus su qualità, compliance e miglioramento continuo.
Retribuzione / Benefits
Responsabilità
- Gestione e revisione dei Master Batch Record
- Supporto alla transizione da cartaceo a eBR
- Emissione e follow-up delle Change Control
- Coordinamento con Produzione, QA, Engineering, Validation per Change Control
- Supporto alle attività di conformità documentale GMP
Requisiti fondamentali
- 2–3 anni di esperienza in contesto farmaceutico GMP
- Uso e gestione documentale di produzione e/o Change Control
- Buona conoscenza delle normative GMP
- Ottima conoscenza dell’inglese (scritta e parlata)
- Buone capacità relazionali e di lavoro in team
- capacità di lavoro in team
- buone doti relazionali
- orientamento alla conformità e al dettaglio
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