Switzerland
MS in Industrial Biotechnology with about 10 years of experience and extended knowledge of Biotech processes, Quality Management System and Facilities Management, Project management, Process Improvement and Troubleshooting activity, Lean Six Sigma and Continuous improvement. Lean Six Sigma Black Belt certification. Direct experience in DS, DP (sterile) and FG production.
Lead the Quality activities for the assigned CMOs for the FG production. Quality Agreements definition, Quality Management review and CMO's validation review and approval, responsible for the whole QMS for the assigned CMOs. Responsible for the Quality Supply chain for the Biosimilar business.
Responsible for the qualification and validation of the final purification equipment and processes (DF/UF, TFF and bag filling for DS production). Lead the project for the clean rooms qualification and release for the whole greenfield DS production site.
Responsabile for Freeze Dry department in terms of Validation and Change Control activities related to Equipment and process. Validation Strategy definition and approval. VMS, VPP, VPR, IQ, OQ, PQ and VR definition and approval. Continuous improvement project lead.
Glaxo Production System Deployment Operational Excellence projects Strategy Deployment Change Management
Production planning, people management, production optimization, GMP projects, OE projects