Rafaella Sanches Email & Phone Number

Brazil

Performing Computer Systems Validation (CSV) in the following systems: SAP HANA, SE Suite, ERP Systems, Excel Spreadsheets with macros development, Laboratory and Manufacturing Systems, applying applicable regulations and guidelines (GMP, FDA, GAMP, 21 CFR part 11).Audit Trail Review Specialist for manufacturing areas and Control Systems.Experienced in international project participation focused on FDA audit preparation.Involvement in infrastructure qualification projects - development of Qualification Plan, Technical Specification, and Protocols.Support for project management and monitoring of deliveries made by team.

São Paulo, Brazil

Perform chemical analyzes on raw material of medicines.

Barueri, São Paulo, Brazil

Perform mechanical tests and analyses such as compression, traction, indentation in polyurethane base products such as flexible foams and rigid foams, both for development and quality control. Interpretation of national and international standards. Produce reports of reporting, organization of the laboratory, planning of tests, control of the samples received.

Barueri

Project planning together with the development area, including feasibility studies for laboratories, better configuration of equipment that is ideal to have routine in the laboratory, development and optimization, validation and uncertainty of methods in instrumental analytical chemistry in the areas of food, environmental, clinical, pharmaceutical, industrial and lab testing for laboratories throughout Brazil.Realization of Layout and Workflow to improve flows of people and samples and optimize time in the routine of analysis, assistance in internal audit documents and implementation of ISO / IEC 17025.Preparation pre and post analytical/instrumental conceptual training, analytical/instrumental practices, troubleshooting, software and quality with preparation of all materials and provide quality training in Portuguese or Spanish.Planning of chemical and instrumental analyses (HPLC, GC, IC, ICP), identifying laboratory infrastructure and resources for performing the analyses, selecting and applying sampling techniques and preservation of samples, researching, selecting and interpreting technical standards.Preparation of test procedures, reports, validation worksheets of methods and audit plans, reports of development of methods, feasibility study reports, internal audit reports, layout reports and workflow contemplating floor plan and budgets.

Bachelor'S Degree, Chemistry

Technical, Chemical Analysis Technician

High School Diploma