Ana Mainardes

Experience

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  Droguinha Drogaria e Perfumaria

  Dec 2003 - Aug 2007

  Administrative assistant

  Administrative services in general, customer service and purchasing.

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  Anfarmag

  Dec 2007 - Apr 2008

  Regulatory Affairs Intern

  Pharmacy regulatory affairs intern. Guidance for members on SNGPC (National Controlled Products Management System), Company Operating Authorizations (AFE) and Special Authorizations (AE) from ANVISA.

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  Organização Farmacêutica Drogão

  Jan 2009 - Mar 2010

  Substitute pharmacist coordinator

  Coordinating pharmacist, customer service, control of psychotropic drugs, application of injectables, team supervision and training, financial services, SEMC and SNGPC.

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  Ebimex Despachos Aduaneiros

  Mar 2010 - Nov 2016

  Pharmacist

  Thermal qualification of thermolabile transport. Maintenance of Good Transport Practices. Renewal of health surveillance licenses. Responsible for the transport department, formation of freight tables, cost management and indicators. Reading the Official Gazette of the Union, State and Municipality. Control of powers of attorney and customer registration in the Merchant Navy.

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  Tecnolog Transportes Rodo-Aéreo E Logística Ltda

  Jun 2012 - Feb 2014

  Consultant pharmacist

  Implementation of good transport practices, in accordance with legislation. Regulatory affairs. Adequacy of physical facilities and procedures. Responsible for quality assurance, facilitator in managing the requirements of the ISO 9001 standard.

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  Gobor Transporte e Logística.

  Sept 2014 - Nov 2020

  Pharmacist

  Implementation of good practices in healthcare storage and transportation. Focal point on issues related to quality management system, housekeeping and health and safety. Responsible for renewing licenses with regulatory bodies. Adequacy of physical facilities and training for all levels.

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  Haidar Transportes e Logística Ltda

  Feb 2017 - Dec 2020

  Dangerous Goods and Products Safety Coordinator / Pharmacist

  Responsible for managing legal requirements, renewing licenses GDP and Dangerous Goods Regulation (DGR). Analysis of Material Safety Data Sheet (MSDS) or Safety Data Sheet (SDS). Internal audits, Corrective and Preventive Action (CAPA), self-inspection, monitoring of external audits and inspections, indicators, training and qualification of suppliers based on Good Practices, ISO 9001, SASSMAQ and the Authorized Economic Operator Program (AEO).

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  Locatrans Transportes e Logística

  Jul 2019 - Dec 2020

  QMS and regulatory affairs coordinator / Pharmacist

  Regularization of the company regarding GDP and Dangerous Goods Regulation (DGR). Implementation of the Quality Management System based on ISO 9001:2015 and SASSMAQ (Health, Safety, Environment and Quality Assessment System). Responsible for implementing the Authorized Economic Operator Program (OAS), developing procedures, Corrective and Preventive Action (CAPA), development of standard operating procedures, monitoring records and evidence, etc.

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  TSA Logística

  Nov 2020 - now

  Management of quality, health and safety (QMS), regulatory affairs and internal audit teams. Ensuring regulatory compliance (GDP and Dangerous Goods Regulation - DGR). Thermal qualification. Validation of computerized systems. Audit and preparation of audit reports, training and continuous improvement. Strategic planning, BSC, risk management, mapping of processes and indicators. Maintenance of ISO 9001 certification. Corrective and Preventive Action (CAPA). Responsible for achieving Authorized Economic Operator Program (OEA), ESG, United Nations Global Compact, Ecovadis and SASSMAQ certifications. Responsible for sustainability, compliance and corporate governance. Show less

  • Healthcare business and quality manager

    Sept 2024 - now

  • Quality and audit manager / Pharmacist

    Aug 2022 - Dec 2024

  • Pharmacist - Quality and Regulatory Affairs Coordinator

    Nov 2020 - Aug 2022