Karina Amancio Fudimura Email & Phone Number

State Of São Paulo, Brazil

São Paulo, Brazil

Update and review of standard operational procedures (SOPs), working procedures (WP) and quality assurance-related documents. Ensure compliance with regulatory standards and specific quality standards for environmental analysis. Conduct internal audits to assess compliance with stablished quality requirements, identify non-conformities and implement corrective and preventive actions. Provide training on laboratory best practices (GLP) and quality procedures for laboratory employees as well as maintain the training records updated. Collaborate on continuous improvement initiatives and identify process optimization opportunities. Keep maintenance and calibration of analytical equipment up to date. Prepare for regulatory inspections and collaborate in responding to external audits.

São Paulo, Brazil

Project management, data analysis for metrics (innovation and digital transformation), implementation and review of Pharmacovigilance Agreements, case processing concerning adverse events from Bayer’s License Partners, reconciliation of individual case safety reports (ICSR), mentoring and training for support team located in India, review and update of working instructions and standard operational procedures (SOP). Job role focused on the quality of processes using several quality tools (PDCA, SWOT and Scrum). Metrics analysis for decision making.Achievements: Automation processes for PV activities • Contributed with a project for strengthen the relationship between outsourced and internal employees • Planning for processes handover, knowledge transfer and presentations to other teams • Lead a weekly meeting for diversity and inclusion dialogues between coworkers

São Paulo

Responsible for review and release the results of quality parameters of environmental samples, continuous improvement of laboratory flow, troubleshooting and implementation of new methods of analysis in physical chemistry laboratory. Main quality tool used for improvement and quick actions was 5W2H. Metrics used for efficiency and strategic decisions.Team leadership, experience in laboratory quality system, critical analysis for continuous improvement of the laboratory system flow. Management of inventory for chemical reagents. Participation in audits and inspections as well as corrective and preventive actions (CAPA) and non-conformities handling. Ishikawa diagram used as quality tool to perform root cause analysis.Achievements: Employee of the year winning award • Successful participation in the scope extension and certification audits • Leadership • People management • Team building • Review and update of the process matrix of an analytical laboratory • Strategic planning with team for meeting delivery deadlines • Workshop presentation to contractual partners • Support to the customer service and purchasing department teams by a technical perspective

São Paulo

Validation, verification, and preventive maintenance of analyzers in a physical-chemical analysis laboratory, ensure of good operation and calibration of analytical methodologies. Writing and review of Standard Operating Procedures (SOP), knowledge of procedures described in the Standard Methods, USEPA and ISO. Implementation of ISO/EIC 17025 and 5S organization method in the laboratory.Experience with equipment: OMNIS, Spectrophotometers, SKALAR, Vario TOC Cube and Ion/Liquid Chromatograph.Achievements: Update and review of SOP according to Standard Methods, ISO, USEPA and ABNT procedures • Storage of chemicals according to ABNT NBR 14725 • Monitoring of the install of OMNIS and other equipment • Creation of method entries using chemical formulas and calculations in LIMS interface

São Paulo E Região, Brasil

Experience with the Ion Chromatograph equipment, which includes preventive maintenance, critical analysis in the treatment of chromatograms and troubleshooting

São Paulo E Região, Brasil

Analysis of environmental samples of water, liquid waste, effluents, and soil in physical-chemical laboratory. Carried out analysis: Quantification of nitrite, nitrate, sulfide and sulfate by spectrophotometry, fluoride by ion-selective electrode and chloride by titration. Experience with equipment: Ion/Liquid chromatograph, including maintenance, data analysis and troubleshooting. Daily interaction with the LIMS portal, reference software for laboratory optimization, where analytical data publications are carried out.Achievements: Best new employee winning award • Team player and efficiency skills in lab for avoiding backlog in analytical methods while equipment was out of use • Good experience in calibration curves

Diadema, São Paulo

Co-orientation of scientific initiation students in research laboratory, production and physical chemical characterization of polymeric nanoparticles of iron, silver and gold.

São Paulo, Brazil

Mestrado, Química / Nanotecnologia

-Production of metallic nanoparticles of iron, gold and silver for parenteral administration as carrier vehicles in biomedical.

Postgraduate Degree, Process And Quality Management

Advanced techniques and strategies to optimize business processes, enhance product or service quality, and drive continuous improvement..

Bacharelado, Chemistry