Associate - QA Supplier Management
4 settimane fa
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.
Il/La **QA Supplier Management Associate **assicura la gestione Quality dei fornitori di API, eccipienti e materiali primari e la compliance della documentazione relativa ai fornitori. Si occupa inoltre di garantire la gestione Quality dei fornitori di GMP consumable e GMP service providers ed è il referente qualità per i fornitori della propria area di competenza.
**Responsabilità principali del ruolo**
- Partecipare alla preparazione di Quality Agreements/Questionnaires, invio e follow up sulla loro approvazione
- Essere il/la responsabile della stesura del rapporto di valutazione annuale dei fornitori di materiali e servizi e proposta della classificazione
- Scrivere procedure per l’area di competenza
- Partecipare alle riunioni/incontri dei fornitori di sua competenza
- Essere il/la referente Quality per il Network sui fornitori di competenza
- Può approvare i changes del settore di sua competenza
- Può approvare gli eventi del settore di sua competenza
- Può partecipare alle Audit presso i fornitori
- Valutare la segnalazione delle difettosità sui materiali
- Gestire i reclami ai fornitori
- Valutare e documentare l’impatto delle Supplier Change Notification
- Redigere report di certificazione
- Redigere gli APR per la parte fornitori/materiali
- Essere Assessor e Lead Investigator per le deviazioni relative ai fornitori
- Essere originator dei Changes relativi ai Fornitori
- Essere assessor dei Changes proposti dai fornitori
- Investigare i changes per impatto su fornitori
**Requisiti richiesti**
- Laurea Magistrale in discipline scientifiche (Chimica, CTF, Farmacia, Ingegneria)
- Conoscenza della lingua Inglese (livello B2/C1)
- Conoscenza dei principali strumenti informatici
- Esperienza nel settore dei materiali e/o materie prime
- Conoscenza dei sistemi di gestione informatica di fabbrica
- Conoscenza delle GMP
**Requisiti aggiuntivi/preferenziali**
- Esperienza pregressa in ambito QA
- Attitudine al team working
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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