Operations Associate

4 settimane fa

Sesto Fiorentino FI, Italia Eli Lilly and Company 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 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.
Job Description Il reparto di produzione del farmaco iniettabile si inserisce nel contesto aziendale all’interno della funzione Operation. Si divide a sua volta in tre unità operative (Formulation and Material Preparation, Filling, Sorting) che, insieme, concorrono rispettivamente alla formulazione, riempimento e ispezionamento del prodotto manifatturato. L’ Operational Associate riporterà al Associate Director dell'area e avrà la responsabilità di seguire lo svolgimento delle operazioni di manifattura cercando di ottimizzarle in termini di fasi e sequenze.
Principali responsabilità del ruolo: Partecipare attivamente come membro fisso al Team cross-funzionale di Processo (Process Team), collaborando con tutte le funzioni per il raggiungimento degli obiettivi e occupandosi direttamente della fase relativa alle operazioni in campo interfacciandosi ed allineandosi con i Supervisori di linea;
Sviluppare ed elaborare il piano di produzione in accordo con i Supervisori di linea e il Process Team;
Collaborare con i Supervisori di linea nel garantire l’esecuzione del piano di produzione, reagendo prontamente a possibili inconvenienti;
Collaborare con i Supervisori di linea per il trasferimento agli operatori delle modalità e sequenze operative stabilite e per la verifica della coerenza fra pratica e procedure;
Verificare sul campo che le attività del reparto siano svolte nei tempi e nei modi stabiliti dalle procedure;
Raccogliere, analizzare e presentare i dati di produzione, le performance del reparto e i KPI;
Raccogliere, analizzare e attuare contromisure relativamente agli errori operativi dell’area e organizzare le riunioni di reparto per la condivisione degli stessi;
Supportare il programma HEP e le pratiche di eccellenza operativa;
Supportare il programma di Practice matches Procedure e le conseguenti azioni migliorative che ne derivano;
Eseguire, su richiesta, investigazioni su deviazioni e osservazioni, scrivere i relativi rapporti e proporre contromisure efficaci per evitare potenziali ricorrenze;
Partecipare alle riunioni di: Shut Down, APS, progetti on-going, allineamento, gestione imprevisti, etc;
Guidare progetti di miglioramento continuo del processo produttivo e di implementazione della metodologia 5S;
Ottimizzare i processi al fine di ridurre la variabilità degli stessi e il possibile impatto sulla produzione;
Partecipare, all’occorrenza in sede di Flow Team, all'attuazione di progetti a breve/medio termine non richiedenti un Project Team;
Essere il punto di contatto lato PT per progetti che impattano il reparto;
Seguire le richieste di modifiche delle Production Procedure che emergono dal campo, interfacciandosi con i PP writer e revisionando le Change Request come Change Owner;
Essere lo SME locale di PMX per quanto concerne le Global Change Request;
Supportare le iniziative di knowledge transfer e di cross-fertilizzazione da/a le altre linee dello stabilimento e da/verso altri stabilimenti;
Essere il punto di riferimento per il Ticket di Manifattura durante le ispezioni;
Assicurare il rispetto delle norme di sicurezza e protezione ambientale.
Requisiti minimi richiesti: Laurea Magistrale ad indirizzo scientifico;
Comprovata esperienza in strutture aziendali manifatturiere ad alta complessità organizzatica o nella delivery di progetti su piattaforme tecnologiche complessi (preferibilmente in ambito farmaceutico );
Ottima conoscenza dei processi produttivi (preferibilmente farmaceutici);
Ottime capacità di lavorare in Team e fare network;
Buona conoscenza della lingua Inglese (capacità di tenere una discussione su tematiche tecniche e capacità di redigere report/assessment in lingua inglese);
Ottima conoscenza delle norme di sicurezza;
Buona conoscenza della gestione amministrativa di fabbrica;
Capacità organizzative e di gestione del personale;
Capacità di lavorare sotto stress.
Requisiti aggiuntivi/preferenziali: Competenze di pianificazione della produzione e delle attività che avvengono nei periodi di shut down;
Buona conoscenza delle GMP e dei processi parenterali (APS e Produzione)
Conoscenze avanzate sul funzionamento e sull’utilizzo di equipment per la preparazione materiali (Washer, Autoclavi, CIP skid, Processori) e delle attività di convalida (iniziale e periodica) degli stessi;
Conoscenza di sistemi MES (PMX) e SAP;
Capacità di leadership e comunicazione;
Precisione e problem solving;
Continuous Improvement mindset;
Esperienza in ispezioni di enti regolatori (AIFA, FDA, etc.).

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