Required experience-            Pharma GMPs main regulations knowledge with at least 8 years experience preferably in role of Manufacturing Science and Technology or Process Validation subject matter expert-            Experience in manufacturing of complex pharmaceutical forms such as aseptic process of drug product, lyophilized products, biological products-            Process Validation and Continuous Process Verification-            Filter Validation-            Single use manufacturing systems-            Aseptic Manufacturing and Media simulation study-            experience in Technology Transfer team (at least 3 years)-            Experience in project management in Technology Transfer projects or similar context-            Risk management -            Documentation Management (SOPs, Specification, Records) -            Deviations/Non-conformities management -            Data integrity-            use of statistical tools and software  Other Desired Experience:-            experience in biotechnology/ biosimilar products (Cell and gene therapy;  Cell culture expansion, harvest, purification, formulation, fill and finish; Blood plasma fractionation and component purification)-            experience in solid oral pharmaceutical forms-            Product Quality review-            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

Location

Italy

Job Overview
Job Posted:
10 months ago
Job Expires:
Job Type
Full Time

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