Qc Biological Laboratory Associate

2 mesi fa

Sesto Fiorentino, Italia Lilly A tempo pieno

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Per lo stabilimento produttivo di Sesto Fiorentino, siamo alla ricerca di un/a **Associate - QC Biological Lab** che, inserito/a all’interno del laboratorio biologico sarà responsabile del rilascio analitico per l’area di competenza assegnata e dovrà fornire supporto tecnico altamente qualificato per l’esecuzione delle attività giornaliere di laboratorio. La risorsa sarà inoltre responsabile di proporre ed implementare progetti di continuous improvement per il Laboratorio.

Le responsabilità della risorsa saranno:

- Assicura l’applicazione delle GMP nel Laboratorio relativamente alle sue aree di competenza
- Fornisce il necessario supporto tecnico analitico altamente qualificato;
- Controlla e assicura la compliance dei metodi analitici a quanto convalidato ed a quanto richiesto dai dossier di registrazione, dalle farmacopee e dalle GMP
- Referente principale del processo di qualifica di metodologie analitiche
- Coordina i progetti e change di Laboratorio di sua competenza
- Esegue e rivede le indagini su osservazioni/deviazioni di Laboratorio garantendone la solidità técnica e la completezza
- Responsabile dell’investigazione di osservazioni relative a fuori limite EM classi C/D
- E’ autorizzato al rilascio dei risultati analitici
- Referente principale per la stesura dell’APR relativo all’area di sua competenza
- Referente principale per la stesura della reportistica periodica relativa alle attività di monitoraggio ambientale (_Laboratorio Biologico_)
- Scrive/rivede procedure e rivede/approva metodi per le aree di sua competenza
- E’ responsabile di proporre e implementare i progetti di continuous improvement del Laboratorio
- Segue iniziative internazionali per l’area di propria competenza

**Requisiti richiesti**:

- Laurea ad indirizzo scientifico (Scienza Biologiche, Biotecnologia o simili)
- Buona conoscenza della lingua inglese (livello minimo B2)
- Conoscenze di microbiologia e di monitoraggio ambientale
- Esperienza di laboratorio e tecniche di analisi
- Conoscenza delle GMP e GLPs
- Attitudine a lavorare in team
- Proattività e autonomia
- Capacità di pianificazione, prioritizzazione e gestione dell’imprevisto
- Attitudine al miglioramento continuo

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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