Emanuel Galati

Trainer for Eurofins-Lancaster Italy on Medical Devices Validation, Statistical tools for Validations, Packaging Validation

Management by influential leadership of all the Validation Engineers in EU and China plants. Participation in Global Project Management and Global Procedure definition Management and active participation in regional and local third parties auditing activities Establishment of synergies between the various department involved in the manufacturing of Medical Devices Establishment of engineers curricula and deployment of training Participation in the establishment of departmental G&Os

Managing; management of a team composed by 5 people: Management of changes related to document change processes Management of site process validations Evaluation and approval of manufacturing materials Management of computer system validation activity Management of Manufacturing Change Control Activities Execution of training on procedures and processes Involvement in definition of global procedures CAPA execution Involvement in audit activities for owned processes

implementation and monitoring of quality system requirements especially on all the validations of processes. Alignment of SOPs to the quality system/compliance requirements Technical evaluations of the design and/or design modifications. Involvement in the preparation and final review of the TF Involvement in the management of auditing by competent authorities and ONs Supplier Quality. Budget preparation Statistical analysis of manufacturing Continuous Improvement Process engineering