REGULATORY DOCUMENTATION SPECIALIST, monza
4 settimane fa
Adecco Italia
monza, Italy
ADECCO ITALIA SPA sta ricercando per importante realtà multinazionale del settore chimico farmaceutico un/a:
REGULATORY DOCUMENTATION SPECIALIST.
Mansioni:
- Supervisionare i progetti assegnati e garantire la conformità alle specifiche normative relative al laboratorio QC PDS per supportare l'avanzamento dei progetti all'interno del Reparto PDS.
- Collaborare con i dipartimenti interni (Produzione, QA, Regolatorio, Logistica, TT/Business) e con i fornitori esterni (Clienti, Laboratori esterni) per implementare specifiche analitiche allineate agli standard di qualità aziendali.
- Gestire le specifiche normative per API, Materiali, Eccipienti e Prodotti Farmaceutici (test di rilascio e stabilità).
- Lavorare con i clienti, il laboratorio e il Regulatory Department per sviluppare specifiche per progetti PDS in conformità con le linee guida ICH e gli standard della farmacopea.
- Fornire consulenza regolatoria e strategica a clienti interni ed esterni sulle specifiche regolatorie e di sviluppo del prodotto.
- Sviluppare strategie specifiche per il progetto e offrire competenze tecniche in materia normativa. Fungere da principale punto di contatto per i clienti chiave, compresa la partecipazione alle riunioni delle autorità di regolamentazione e alle attività di pubbliche relazioni.
- Garantire la conformità alle normative cGMP e agli standard di qualità, contribuendo alla gestione delle deviazioni, ai CAPA e ai controlli delle modifiche per tutte le fasi dei progetti PDS.
- Elaborare, rivedere e aggiornare le procedure nell'area di competenza, garantendo il rispetto delle normative, delle leggi e degli standard GMP.
Requisiti:
- Laurea Magistrale in Chimica Farmaceutica o Biologia o Chimica o Biotecnologie o similari.
- Esperienza pregressa in laboratori di analisi o in laboratori di tecnologia farmaceutica.
- Conoscenza degli standard GMP.
- Dimestichezza con la gestione dei dati, i sistemi di valutazione, i test di stabilità e di routine per API e prodotti finiti.
- Inglese fluente sia a livello scritto che parlato.
- Buone capacità organizzative e di pianificazione.
Data inizio prevista: 17/03/2025
Categoria Professionale: Servizi Professionali
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Monza (Monza E Della Brianza)
Esperienza lavorativa:
- Regulatory affairs specialist - 12 mesi
Istruzione:
- Laurea Magistrale - Chimico / Biologico / Ambientale - Chimica e tecnologia farmaceutiche
Conoscenze linguistiche:
- Inglese - Livello Ottimo
Patenti:
- B
Disponibilità oraria:
- Full Time
Benefit previsti: Ticket restaurant da 8,00
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