Macherio, Lombardy, Italy
During my career I have combined deep experience and knowledge from both Quality and Manufacturing areas of the Sterile Pharmaceutical industries. I covered responsibility roles in Quality Control, Quality Assurance, Manufacturing and Technology Transfer in the world of aseptic processing operations (Lyophilized, Liquid and Powder). I have managed several inspections from different regulatory bodies, (e.g. AIFA, FDA, ANVISA, PMDA) in both role of Quality or Manufacturing leader. I love creating an environment where each person can express ideas and collaborate to reach common objectives. Continuous improvement has been key factor in transforming the organization I have managed. I’m a certified Green Belt and tools derived from Six Sigma, Operational Excellence and Lean helped me and my team in defining strategy and achieving results. I truly believe that the “person” is a key factor for success of the organization and over the years my role has been focused on helping people to develop themselves reaching coming goals. The direct involvement in “non-routinary” projects helped me to develop organization skills. Project Management and Technical Transfer activities were significantly important for my growth.
Manufacturign Director responsible for Injectables manufacturign operations (bulk and finished products). Direct management of following main activities: - Interaction with Regulatory Bodies during inspections (AIFA, MHRA, FDA, etc.). - Customer interactions management (Feasibility analysis, technical discussion, master plan). - Identification of process development opportunities - Implementation of SAP integrated solution in particular for Manufacturing Operations. - Application of Lean in Manufacturing Operations - Management relations with Corporate functions and worldwide plants. - Direct involvement in Project Management and Technology Transfer - Personnel development and organization development. - Year Plan budget definition and management during the year. - Development of Customer quotation for Customer or Internal use. Management of Manufacturing Department constituted by the following groups: - Lyophilization Department. - SVP Ampoules Department (Aseptically filled and Terminal sterilized) - Powder Filling Department (Aseptically filled) - Packaging Department - Manufacturing Process Development Department
Manufacturign Director responsible for Injectables manufacturign operations (bulk and finished products). Direct management of following main activities: - Interaction with Regulatory Bodies during inspections (AIFA, MHRA, FDA, etc.). - Customer interactions management (Feasibility analysis, technical discussion, master plan). - Identification of process development opportunities - Implementation of SAP integrated solution in particular for Manufacturing Operations. - Application of Lean in Manufacturing Operations - Management relations with Corporate functions and worldwide plants. - Direct involvement in Project Management and Technology Transfer - Personnel development and organization development. - Year Plan budget definition and management during the year. - Development of Customer quotation for Customer or Internal use. Management of Manufacturing Department constituted by the following groups: - Lyophilization Department. - SVP Ampoules Department (Aseptically filled and Terminal sterilized) - Powder Filling Department (Aseptically filled) - Packaging Department - Manufacturing Process Development Department
Direct management of the following main activities: - Management of contact and follow-up with Regulatory bodies: AIFA, MHRA and FDA (deficiency letter, audit, action plan, etc.). - Customer interactions management (Technical meeting and discussion, main project deliverables, Quality impact). - Relation with Corporate functions and world wide plants. - Direct involvement in Project Management and Technology Transfer - Organization and management of Audits (Regulatory bodies, Customer and Corporate) - Management of internal significant quality projects and inter-departments projects. - Review of CTD documentation and evaluation of regulatory impact. - Management of Recall process and investigation process (high level issues). - Personnel development and organization development. - Year Plan budget definition and management during the year. - Development of Customer quotation for Customer or Internal use. Management of Quality Assurance Department constituted by the following groups: - Documentation & Training Department: development of GMP documentation and training (process, analytical, test methods, specification, etc). - Internal & External Audit Department. - Artwork Department : artwork development and change management. - Quality Systems: investigations, CAPA, Complaint, Annual Product Review and QP Release process. - Validation Department:validation activities for all system with GxP impact (PQ, Process Validation, Holding Time Validation, Cleaning Validation, etc). - Quality Control Department: Chemical, Biological and Incoming labs - Stability Department: ICH and ongoing stability and stability trend analysis
- Management of routine analytical activities (schedulign, problem solving, etc.) and exceptional activities (investigations) of Chemical and Microbiological Laboratory. - Development and alignment of common procedures in order to streamline the processes between the two labs. - Direct involvement in the design, start-up and validation of a Small Volume Parenteral Department (Terminal Sterilization and Aseptic Filling) with particular involvement in Sterility Assurance aspects. - Direct involvement during the Authorities inspection required to authorize the new Small Volume Parenteral Department.