Product Compliance Specialist
4 settimane fa
Il nostro obiettivo è assicurare la conformità dei prodotti a normative e regolamenti vigenti, garantendo la qualità e la sicurezza dei nostri farmaci.
Responsabilità principali- Avere la responsabilità dell'approvazione dei lotti bulk e semilavorati
- Revisione e approvazione della documentazione batch record
- Gestione delle non conformità e azioni correttive
- Collaborazione con QC Services, Planning & Logistica per assicurare la disponibilità del prodotto
- Gestione dei reclami di qualità e coordinamento delle azioni correttive
- Annual product review
- 2-3 anni di esperienza nelle aree di gestione della Qualità
- Avere maturato esperienza nella gestione di prodotti sterili
Laurea in discipline scientifiche, preferibilmente Chimica e Tecnologie Farmaceutiche, Farmacia, Biologia o Chimica
LingueBuona conoscenza della lingua Inglese (sia scritta che parlata)
Competenze Tecniche- Ottima conoscenza della legislazione farmaceutica internazionale
- Conoscenza delle norme della serie ISO 9001:2008
- Conoscenza dei processi asettici e dei concetti di Sterility Assurance
- Orientamento alla qualità
- Orientamento al risultato
- Adattabilità e flessibilità
- Problem solving
La disponibilità a lavorare su turni è richiesta
Entreresti a far parte di un ambiente dinamico e amichevole, dove le persone sono il bene più prezioso. Chiesi Group investe nella formazione continua e apprendimento, per garantire il miglioramento costante delle esigenze di sviluppo, della qualità del lavoro e del benessere collettivo. Offriamo un approccio di lavoro flessibile e supporto nel processo di trasferimento.
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