Karina Amancio Fudimura

Karina Amancio Fudimura Email and Phone Number

MSc | ISO 17025 | Quality Assurance | Quality Control @ VSOL GROUP
Karina Amancio Fudimura's Location
São Paulo, São Paulo, Brazil, Brazil
Karina Amancio Fudimura's Contact Details

Karina Amancio Fudimura personal email

About Karina Amancio Fudimura

Master's degree in Science and Technology of Sustainability (Federal University of São Paulo, 2016) and Bachelor's degree in Chemistry (Federal University of São Paulo, 2014). Currently pursuing post graduation degree in Process and Quality Management (UNINTER, 2024 - in course).Qualified chemist with experience of 5 years in laboratory and good laboratory practices (GLP) in the environmental industry and in academic research. Professional with expertise in quality assurance of laboratory management, quality control of environmental matrices, data analysis, interpretation, and review. Professional performance for almost 3 years in well-known global pharmaceutical industry, job role focused on quality of processes, with activities that includes pharmacovigilance, CAPA, continuous improvement, SOP and WP writing and review.Experience with metrics (KPIs), TAT, deadline for results delivery and organization.Successful participation in audits for maintenance of lab accreditation, certification, and scope extension. Active CRQ-IV register (Regional Council of Chemistry in Sao Paulo, Brazil).Brazilian Portuguese native speaker, fluent English, and basic Spanish.

Karina Amancio Fudimura's Current Company Details
VSOL GROUP

Vsol Group

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MSc | ISO 17025 | Quality Assurance | Quality Control
Karina Amancio Fudimura Work Experience Details
  • Vsol Group
    Quality Assurance Analyst
    Vsol Group Feb 2024 - Present
    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.
  • Captativa Consultoria Em Recursos Humanos
    Pharmacovigilance Analyst (On Behalf Of Bayer)
    Captativa Consultoria Em Recursos Humanos Dec 2020 - Sep 2023
    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
  • Als
    Qc Laboratory Supervisor
    Als Jan 2019 - Dec 2020
    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
  • Als
    Laboratory Analyst
    Als May 2018 - Jan 2019
    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
  • Als
    Junior Laboratory Analyst
    Als Oct 2017 - Apr 2018
    São Paulo E Região, Brasil
    Experience with the Ion Chromatograph equipment, which includes preventive maintenance, critical analysis in the treatment of chromatograms and troubleshooting
  • Als
    Auxiliar De Laboratório
    Als May 2017 - Oct 2017
    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
  • Universidade Federal De São Paulo
    Research Collaborator
    Universidade Federal De São Paulo Jan 2016 - 2017
    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.
  • Curso Anglo Vestibulares
    Administrative Assistant
    Curso Anglo Vestibulares Mar 2006 - Apr 2008
    São Paulo, Brazil

Karina Amancio Fudimura Skills

Microsoft Office Microsoft Excel Microsoft Powerpoint Microsoft Word Pesquisa Desenvolvimento De Produtos Pesquisa E Desenvolvimento Research Powerpoint English

Karina Amancio Fudimura Education Details

Frequently Asked Questions about Karina Amancio Fudimura

What company does Karina Amancio Fudimura work for?

Karina Amancio Fudimura works for Vsol Group

What is Karina Amancio Fudimura's role at the current company?

Karina Amancio Fudimura's current role is MSc | ISO 17025 | Quality Assurance | Quality Control.

What is Karina Amancio Fudimura's email address?

Karina Amancio Fudimura's email address is ka****@****ail.com

What schools did Karina Amancio Fudimura attend?

Karina Amancio Fudimura attended Universidade Federal De São Paulo, Centro Universitário Internacional Uninter, Universidade Federal De São Paulo.

What skills is Karina Amancio Fudimura known for?

Karina Amancio Fudimura has skills like Microsoft Office, Microsoft Excel, Microsoft Powerpoint, Microsoft Word, Pesquisa, Desenvolvimento De Produtos, Pesquisa E Desenvolvimento, Research, Powerpoint, English.

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