Fernanda Andrade

Fernanda Andrade Email and Phone Number

Analista de Sistemas de Qualidade @ Fundação Butantan
State of São Paulo, Brazil
Fernanda Andrade's Location
São Paulo, São Paulo, Brazil, Brazil
Fernanda Andrade's Contact Details

Fernanda Andrade work email

Fernanda Andrade personal email

About Fernanda Andrade

Bachelor's degree in Chemistry. Fluent English. Experience in preparing, reviewing and maintaining documentation related to the Design and Development of new products in the area of ​​Medical Devices and in Quality Assurance, managing technical complaints, non-conformities, audits, preparation and monitoring of Quality Indicators, investigations, process improvements and production documents, with extensive experience in computerized systems such as SoftExpert, TrackWise and SAP. Certifications: ISO 9001:2015, ISO 14971:2007, ISO 13485:2016.

Fernanda Andrade's Current Company Details
Fundação Butantan

Fundação Butantan

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Analista de Sistemas de Qualidade
State of São Paulo, Brazil
Employees:
1995
Fernanda Andrade Work Experience Details
  • Fundação Butantan
    Analista De Sistemas De Qualidade
    Fundação Butantan
    State Of São Paulo, Brazil
  • Fresenius Kabi
    Quality Assurance Analist
    Fresenius Kabi May 2024 - Present
    Itapecerica Da Serra, São Paulo, Brazil
    Responsible for investigating market complaints, focusing on data analysis. Developing KPIs, risk analysis (FMEA), preparing reports and conducting management meetings to analyze results and KPIs. Investigating deviations, root cause analysis (Ishikawa, 5 whys) and checking the effectiveness of proposed corrective actions. Writing and reviewing operating procedures (SOPs). Reconciliation of production documentation for batch release.
  • Fresenius Kabi
    Research And Development Analyst
    Fresenius Kabi Oct 2022 - Apr 2024
    Itapecerica Da Serra, São Paulo, Brazil
    Product transfer project management, new product project management and product change project management.Impact assessment for the implementation of new products in the factory.Preparation of product design control documentation such as project inputs, product lists and project history records. Preparing schedules and change controls and following up action plans.Monitoring the production of new products, making adjustments to implementation plans if applicable.Interface with the implementation of new standards with an impact on the product.Communication with corporate development teams to develop new product projects or product changesMonitoring stability studies.
  • Elanco
    Quality Assistent
    Elanco Dec 2021 - Apr 2022
    Belford Roxo, Rio De Janeiro, Brazil
    Belford Roxo site plant shutout project activities related to the decommissioning of the quality control laboratory such as GMP documentation archiving, stocktaking of retention materials, instruments and glasswares and also demobilization of equipments.
  • Fresenius Kabi
    R&D Analyst
    Fresenius Kabi Mar 2018 - Jan 2021
    Itapecerica Da Serra, São Paulo, Brasil
    Elaboration of specifications and artwork for products, IFUs, labels and cartoon boxes, to meet regulatory standards review, new product development processes, bidding processes, implementation of resale products and product license renewal processes. Management of product and raw material specifications in a computerized system with the activities of inclusion, review and obsolescence of respective documents. Specification change management through change control. Execution of tests and evaluations of new products and materials during the development phases. Master data management of productive and non-productive materials in ERP system (SAP).
  • Fresenius Kabi
    Junior Quality Assurance Analyst
    Fresenius Kabi Aug 2015 - Feb 2018
    Itapecerica Da Serra, São Paulo, Brasil
    Responsible for activities of quality management in which concerns the analysis of regulatory standards, creation and revision of SOPs and also training.Planning, conducting and executing internal audit program. Elaboration of quality indicatorsconducting investigation of non-conformities and elaborating of action plans. Implementation of corrective and preventive actions.Verification of the effectiveness of action plans by monitoring of production processes. Elaboration and implementation of process mapping and work instructions.
  • Fresenius Kabi
    Quality Assurance Assistant
    Fresenius Kabi Jan 2014 - Jul 2015
    Itapecerica Da Serra, São Paulo, Brasil
    Management of technical complaints, through analysis of complaint samples, in addition to opening, reviewing and closing investigation reports.Elaboration of quality indicators and development of product and process risk analysis using FMEA. SOP creation, monitoring of deviations and action plans.
  • Innovadex
    Freelance Translator
    Innovadex Nov 2013 - Apr 2014
    São Paulo E Região, Brasil
    Service provider of English / Portuguese translation of chemical product's descriptions.

Fernanda Andrade Skills

Powerpoint Sap Iso 14971 Autocad Microsoft Windows Windows Gmp Iso Microsoft Powerpoint Pesquisa English Outlook Minitab Microsoft Office Microsoft Word Microsoft Excel Microsoft Outlook Ms Project Microsoft Project Adobe Illustrator

Fernanda Andrade Education Details

Frequently Asked Questions about Fernanda Andrade

What company does Fernanda Andrade work for?

Fernanda Andrade works for Fundação Butantan

What is Fernanda Andrade's role at the current company?

Fernanda Andrade's current role is Analista de Sistemas de Qualidade.

What is Fernanda Andrade's email address?

Fernanda Andrade's email address is fe****@****ail.com

What schools did Fernanda Andrade attend?

Fernanda Andrade attended Mba Usp/esalq, Universidade Federal De São Paulo.

What are some of Fernanda Andrade's interests?

Fernanda Andrade has interest in Indústria Química, Farmacêutica E De Alimentos, Cosmética.

What skills is Fernanda Andrade known for?

Fernanda Andrade has skills like Powerpoint, Sap, Iso 14971, Autocad, Microsoft Windows, Windows, Gmp, Iso, Microsoft Powerpoint, Pesquisa, English, Outlook.

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