Dossier Compliance Specialist
IBSA Institut Biochimique SA
IBSA Group Responsabilità principali
- Aggiornare, mantenere e gestire la documentazione QC e i dossier di qualità
- Verificare la conformità della documentazione rispetto a procedure interne, linee guida regolatorie e farmacopee
- Supportare il team Quality Control nella raccolta, verifica e consolidamento delle informazioni tecniche
- Applicare strumenti statistici a supporto delle attività di analisi e revisione documentale
- Collaborare con le funzioni coinvolte per garantire coerenza e tracciabilità della documentazione di qualità
- Conoscenza dei prodotti farmaceutici dal punto di vista analitico, di processo produttivo e delle specifiche(preferenziale esperienza su prodotti sterili/iniettabili)
- Familiarità con dossier e procedure regolatorie, linee guida e farmacopee
- Competenze di base in ambito statistico
- Esperienza nella redazione e gestione di documentazione tecnica
- Preferibile esperienza pregressa in laboratorio chimico
- Conoscenza di sistemi gestionali in ambito farmaceutico (es. ERP, LIMS, QMS)
- Precisione, flessibilità e predisposizione al lavoro in team
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