Emanuele Volpe

Gmp Compliance Advisor & Auditor - Third Party Audit Operations Unit Manager @PQE Group

Roma, IT

Extensive experience in support to Pharmaceutical Quality System compliance through development/review of:• Quality Management Plans• FDA / EU cGMP compliance Assessment• ALCOA+ and Data Integrity Assessment• Non-conformances reporting and management• Complaints and CAPA management• Deviation Management and Root Cause Analysis• Change Management• FDA, EU, CFDA, ANVISA Inspection Preparation• Quality Risk Management• Cross-Contamination Prevention• Cleaning Validation• Process Validation• Processes Mapping and Analysis• Editing/Review of Standard Operating Procedures (Process and Management SOPs)• Editing/Review of Batch Records• Editing/Review of Pharmaceutical Production ReportsExtensive experience in support to Auditing systems for Pharma and API quality systemsProject Management / coordination activities through development/review of project plans/Gantt, status update reports/presentation, project issues tracker and technical problem solving, resources workload plans, meeting agenda/minutes, budget monitoring, with emphasis on:• Wide Knowledge of different Project Methodologies (waterfall, critical chain, agile, scrum, etc.)• Demonstrated ability to effectively collaborate with Cross-Functional Teams• Experienced in Collaborating with Key Stakeholders to ensure the optimal project scope planning as well as ensuring appropriate corrective and preventive actions are completed in a timely manner (WBS, Project Planning, GANTT Management)• Responsible for effectively initiating, planning, scheduling, estimating, forecasting, coordinating, controlling, managing and delivering all activities and costs for projects and related release initiatives• KPI Management• Good communication and interpersonal skills, capability to work independently as well as in teams with technical, administrative and business staff