Un/a specialista
IBSA Institut Biochimique SA
IBSA Group
API QA Specialist
Mansioni
- Assicura la Qualità nella fabbricazione di API
- Revisione di batch record di API e rilascio a sistema informatico
- Gestione delle deviazioni di processo
- Gestione delle azioni correttive e/o preventive
- Redazione, revisione e approvazione SOP
- Revisione e/o approvazione MBR, MAN
- Approva anagrafiche, codici, materiali, ricette, etc a sistema informatico per la fabbricazione di API
- Stesura di Product Quality Review (PQR)
- Garanzia del rispetto dei requisiti normativi e qualitativi del settore, norme cGMP
- Supporto al Change Control Process
- Follow-up di osservazioni di qualità
- Supporto durante Ispezioni ministeriali e Audit da parte di clienti esterni
Profilo richiesto
- Laurea in discipline scientifiche, preferibilmente in Farmacia, Chimica e Tecnologie Farmaceutiche, Biologia o Biotecnologie.
- Almeno tre anni di esperienza nel ruolo, maturata all’interno di aziende farmaceutiche in ambiente Active Pharmaceutical Ingredients e/o Finished Products
- Esperienze pregresse in ambito farmaceutico GMP, GLP e/o GDP.
- Buona conoscenza della lingua inglese (scritto e orale)
- Conoscenza dei termini, degli strumenti e delle metodologie QA
- Conoscenza approfondita delle cGMP e delle normative di riferimento (EudraLex Vol. 4, 21 CFR part 210, 211)
- Ottime capacità relazionali e di negoziazione
- Orientamento alla risoluzione di problemi
- Proattività
Die Stellenanzeige wurde vor Vor 10 Tagen veröffentlicht
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