Antonio Petti Email & Phone Number

Consolidate experience in Organization of the quality management system and related personnel, production and laboratories management. Very good competence in the coordination and management of the Quality Control, Research & Development, Quality Assurance and Validation teams.Project management of external laboratory and research teams for Patents and Pubblications.Strategic thinking to make difficult decisions and provide solutions of complex projects. Consolidate competence in generic drugs development and management of their production and control flows. Consolidate competence in drug products for clinical trials. National and european dossier and technical files submissions (about 200 dossiers submission and follow-up).Consolidated competence and experience in audit with Italian, European and non-European authorities for authorization and periodic visits (Italian authorities (AIFA), Brazilian authorities (ANVISA), Russian authorities, Chinese authorities, Turkish authorities, etc.). Consolidate competence in relationship with national and international autorities and auditors for the management of: CAPA, non-conformities, deficiency letters, recalls, complaints, submissions, patents, Research & Development projects and Ministry of Economic Development projects.Consolidated competences in start-up of new pharmaceuticals industrial plants and/or new departments.Layout drawing and construction management of the entire production site (Alfa Instruments s.r.l. production, laboratories, warehouses, utilities and offices).Layout drawing and construction management of the new vials department with blow-fill-seal technology (BFS)(four at Genetic s.p.a., one at Alfa Intes s.r.l.) and its start-up, technological transfer of finished products .Layout drawing and construction management of four new oral solid departments (Genetic s.p.a.), also high-activity substances (Anticancer, Steroids and immunosuppressants).Layout drawing and construction management of new MDI department (Genetic s.p.a.).Consolidated experience in industrial plants in environmental and process validation. Layout drawing and construction management of the entire site for large volume injectable (Panpharma srl production, laboratories, warehouses, utilities and offices).Improvement and optimization of production flows and controlled contamination environments Good knowledge of ISO standards and of GMP and GLP guidelines.Good knowledge of European guidelines on the preparation of the European CTD. Good ability to write CTD and overall quality summary.

Listed skills include Industria Farmaceutica, Project Management, Microsoft Office, Management, and 2 others.

• 

  Università Degli Studi Di Napoli 'Federico Ii'​

  110/110