• Responsible for the validation process of new product’s manufacturing and packaging processes in Monza site;
• Drawing up Process and Cleaning Validation Protocols and Reports for Clinical,
Registration, Validation batches manufacturing of sterile lyophylized, liquids drug products (vials, pre-filled cartridges or syringes) and secondary packaging processes (labeling and serialization steps), in accordance with GMP and corporate standards;
• Support in drawing manufacturing instructions (MBR);
• Statistical processing of data through computer applications (Excel/Minitab);
• Change control management;
• Supervisioning production activities in classified environments; involvement in
Media fill, overlooker and fit&finish activities in production department for Sterility Assurance;
• Strong cooperation with technology transfers- project managers for technology transfers activities; strong interaction with other Departments;
• Participation in internal meetings or meetings with Clients.