Agent expected skills: Pharma GMPs main regulations knowledge (at least comprehension and/or ability to work on): -        Technology Transfer: at least 4/5 years of experience in a TT team as Process Technology SME (alias process Manufacturing Science and Technology/Process Engineer) or Process Validation SME -        Experience in project management in TT projects or similar context-        Management or involvement in an average number of TT projects (not less than 5 )-        Experience in manufacturing of complex pharmaceutical forms such as: aseptic process of drug product, lyophilized products, biological products, biotechnology/ biosimilar products Cleaning Validation experience
Other Desired Experience:-            Developing Validation / Verification Master Plans-            Performing formal risk assessments / FMEA-            Change Control -            CAPA process -            Identifying Critical Attributes and Critical Process Parameters-            Commissioning and Qualification-            Developing User Requirements-            Schedule development and execution-            Establishing metrics and leading team to achieve performance goals-            Facilitating meetingsLa selezione rispetta il principio delle pari opportunità (l. 903/77)#LI-AG1