Summary
* Shift Lead I
* Il Shift Leader è responsabile della gestione del suo team per eseguire le operazioni di produzione secondo il programma in conformità con le norme HSE e GMP.
* Specialista di processo / Specialista di apparecchiature
* Eseguire le attività e le attività di produzione assegnate in base al programma di produzione per consentire la produzione tempestiva del prodotto con la qualità e la quantità in conformità con le GMP, la sicurezza e le linee guida ambientali pertinenti.
* Specialista della documentazione GMP
* Lo specialista della documentazione GMP esamina e consolida i record dei lotti dopo la produzione al fine di consegnarli al controllo qualità acc. per impostare le tempistiche e nella giusta qualità. Il Documentation Specialist GMP esegue le registrazioni e verifica le transazioni/dichiarazioni nel sistema ERP.
About The Role
Key responsibilities:
1. Working in shifts, perform the necessary activities for the preparation and production of batches.
2. Perform routine maintenance and cleaning, periodic microbiological verification of pharmaceutical areas and equipment, and support external specialized personnel in carrying out extraordinary maintenance/qualification activities.
3. Promptly report to the Production Manager and the Qualified Person any deviation and/or out of specification detected during the production process.
4. Perform incoming and outgoing verification activities of raw materials and materials.
5. Collaborate with the Production Manager to the management of material stocks and waste materials.
6. Collaborate with the Production Manager to the training of new personnel.
Essential Requirements
* Scientific/technical background.
* Willing to work in shifts, including night shifts.
* Fluent in Italian. Good knowledge of English.
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