Stage Corporate Quality System

6 mesi fa


Rome, Italia Dompè A tempo pieno

**Contesto lavorativo**:
Il tirocinio formativo si svolge nell’ambito del reparto Corporate Quality System della Divisione Quality Assurance della sede direzionale di Dompé Farmaceutici di Milano.

Il reparto è dedicato alla gestione del _Quality System_ aziendale a livello _Corporate_ nonché degli aspetti quality correlati alle attività di gestione dei fornitori di specialità medicinali, integratori, medical device e cosmetici.

**Contenuto progetto formativo**:
Il progetto è mirato all’acquisizione di competenze in ambito Quality Assurance attraverso l’erogazione della formazione tecnico/normativa di base per la gestione delle attività correlate alle produzioni di specialità medicinali conto terzi.

Il progetto formativo sarà articolato in 3 fasi prevedendo:

- **Fase-I**: formazione teorica di base su Good Manufacturing Practices (GMP)/ Good Distribution Practices (GDP)
- **durata: 15gg**
- **Fase-II**: training on the job in affiancamento con il tutor di progetto, per l’acquisizione delle conoscenze di base per l’utilizzo dei sistemi e delle procedure operative richieste per la gestione delle attività sopra indicate - **durata: 15gg**
- **Fase-III**:assegnazione di un progetto specifico, mirato alla verifica del livello di competenze acquisite, attraverso l’esecuzione pratica delle attività (ad esempio: gestione del file di monitoraggio delle attività di gestione dei produttori di specialità medicinali conto terzi) - **durata: 5 mesi**

**Competenze/conoscenze/abilità tecnico professionali acquisite al termine del progetto formativo**

Di seguito gli obbiettivi formativi che si intendono perseguire nel corso del tirocinio professionale oggetto di richiesta:

- Capacità di supportare la Divisione:
nella revisione dei Quality Technical Agreement (QTA)

nell’organizzazione degli audit alle terze parti e nella gestione dei follow-up

nella revisione di richieste di change, deviazioni, protocolli/rapporti di convalida e di stabilità

nella verifica della documentazione di rilascio di lotti di specialità medicinali conto terzi

nella gestione delle richieste di informazioni/documentazione ai/dai produttori di specialità medicinali conto terzi
- Capacità di organizzare l’archivio della documentazione técnica della Divisione relativamente alle attività correlate con la gestione delle terze parti
- Capacità di gestire il file di monitoraggio delle attività di gestione dei produttori di specialità medicinali conto terzi

**Il tirocinante sarà inserito all’interno della Direzione Quality Assurance a diretto riporto del responsabile del reparto Corporate Quality System.



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