André Picoli

Biography

Nineteen years of solid experience in the Pharmaceutical Industry, with operations in Technical Management and Management Teams in the areas of Quality Assurance, Quality Control, Regulatory Affairs and Production.  - Expertise in strategic planning areas of Quality and Regulatory Affairs, striving for excellence in quality system and participating in the development of investment plans for expansion of areas, acquisition of new equipment and management costs.  - Start-up manufacturing plant - Fresenius Medical Care Brazil, focusing on Quality Control Laboratory, working on the layout definition, acquisition of equipment, materials and standardization of methods and specifications.  - Reducing costs of materials, inventory, elimination of bottlenecks and optimization of areas and processes in the laboratory, production and administration.  - Preparation, analysis and monitoring of Budget and Headcount, focusing on management and cost reduction.  - Development of suppliers of productive materials in conjunction with the Purchasing Department, seeking cost reduction and quality improvement.  - Monitoring and performance analysis of the quality system by collecting data and producing statistical reports and metrics to identify improvement opportunities, which will be reflected in action plans at the operational level.  - Management program of complaint relating to market quality products.  - Effective participation in study groups and the actions involving the registration of new products.  - Approval files of new product registrations and renewals of registrations of products portfolio.  - Administration of human resources in terms of training, motivation and professional development.  - Advanced knowledge in computer science. User of SAP, JDE and Microsiga system.  - International travel through US, Latin America and Asia to conduct issues relating to Quality

Research Interest

Solid experience in making and receiving internal and external audits (suppliers, corporate and regulatory agencies) focusing on the Good Manufacturing Practices standards established by the ANVISA, INVIMA, MERCOSUR, CE Mark, FDA and ISO.  - Strong experience in implementing the Lean Manufacturing Philosophy (TPS - Toyota Production System) acting as agent in integrating leadership team and senior management, ensuring the deployment of new culture aligned with company strategy.