Carine Siffert

MBA Professor at Pós Graduação - Faculdades Oswaldo Cruz
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Contact Information
us****@****om
(386) 825-5501
Location
São Paulo, São Paulo, Brazil, BR
Languages
  • English Full professional proficiency
  • Spanish Professional working proficiency
  • Português Native or bilingual proficiency

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Tatiane Ramos, MScRes

A Carine reúne diversas qualidades primordiais na seara corporativa, no dia a dia laboral. Empatia, carisma, trabalho em equipe, sagacidade, persistência, comunicação e principalmente humildade a tornam um recurso primordial em qualquer equipe de sucesso. Ela sabe fazer a diferença!

Victor A. Tavares

Tive a honra e privilégio de trabalhar com Carife Siffert e posso afirmar que ela é uma das profissionais mais dedicadas e competentes que já conheci. Carife possui uma abordagem singular, combinando um profundo conhecimento técnico com uma habilidade notável de gestão de pessoas. Ela não apenas entende processos complexos, mas também tem a capacidade ímpar de alinhar esses processos à gestão de pessoas de forma eficaz. Sua mente diferenciada, sempre voltada à inovação e otimização, torna-se ainda mais notável quando combinada à sua natureza amigável e parceira. Carife estabelece um ambiente de trabalho onde o respeito é a pedra angular, e isso reflete na forma como todos, seja trabalhando diretamente com ela ou indiretamente, sentem-se valorizados e motivados a dar o seu melhor. Sua gestão é sinônimo de eficiência e humanidade, e é raro encontrar alguém que consiga equilibrar tão bem esses dois aspectos. Recomendo Carife Siffert sem reservas para qualquer empresa ou projeto que valorize a excelência em gestão e liderança. Seu impacto é certamente transformador.

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Credentials

  • ISO 9001:2015 / ISO 13485:2016
    QUALICALL TREINAMENTO E ASSESSORIA LTDA.
    Jun, 2021
    - Nov, 2024
  • ISO 14971:2004/EN 14971:2012
    SGS Academ
    Jun, 2018
    - Nov, 2024
  • Computer Systems Validation
    CEP. CENTRO DE ESTUDOS PROFISSIONAIS
    Jul, 2012
    - Nov, 2024
  • Six Sigma Green Belt
    QSC Quality Solution Consultoria
    Nov, 2010
    - Nov, 2024
  • Intensive Course on Regulatory Affairs and Medicament Registration
    Instituto Racine

Experience

  • Pós Graduação - Faculdades Oswaldo Cruz
    • Brazil
    • Education Administration Programs
    • 100 - 200 Employee
    • MBA Professor
      • Aug 2023 - Present

      Teaching in the Module of Integrated Management, Quality System and Good Pharmaceutical Practices, of the MBA in Pharmaceutical Logistics Chain Management. Teaching in the Module of Integrated Management, Quality System and Good Pharmaceutical Practices, of the MBA in Pharmaceutical Logistics Chain Management.

  • Instituto Racine
    • Brazil
    • Higher Education
    • 1 - 100 Employee
    • Technical Teacher
      • Dec 2022 - Present

      Teaching about the themes of: Quality Assurance Risk Management Logistic Teaching about the themes of: Quality Assurance Risk Management Logistic

  • Stark-4PL
    • Brazil
    • Transportation, Logistics, Supply Chain and Storage
    • 1 - 100 Employee
    • Quality and Regulatory Affairs Manager| Responsible Pharmacist
      • Sep 2022 - Present

      • Reporting to the general Manager and responsible for the management of the Quality Assurance system. • Responsible for the flow and coordination of qualitative control of the cold chain logistics process of products for Brazil. • Responsible for quality strategy for supplier qualification. • Elaboration and implementation of procedures, according to CBPDA specifications. • Responsible for route mapping and risk analysis. • Responsible for ensuring compliance with audits. • Responsible for supporting the Commercial team to meet customer requirements, promoting the choice of technology used in the company. • Implementation of quality practices and compliance with Health Surveillance. • Management of regulatory processes, granting of AFE and license documentation. • Member of the Committees for the implementation of good practices at ANVISA, Pharmaceutical and Cold Chain at ABRALOG. • Responsible for the control of imported products and ensuring the engagement of teams in relation to quality processes. • Implementation of systems to meet the health requirements of RDC 430/2020 and RDC 653/2022 and other current and applicable regulations. • Updating procedures in compliance with the QMS and new operations in Brazil. • Elaboration of non-conformity processes and corrective/preventive action plan. • Monitoring and qualification of suppliers, consultancies and internal, external and regulatory audits. • Customer development through pre and post market analysis. Show less

  • BLS - Biothermal Logistics Solutions
    • Brazil
    • Transportation, Logistics, Supply Chain and Storage
    • 1 - 100 Employee
    • Quality Manager | Responsible Pharmacist
      • Oct 2020 - Feb 2022

      • Reporting to the CEO and responsible for the management of the Quality Assurance system, leading 2 people. • Responsible for the flow and coordination of qualitative control of the cold chain logistics process of products for Brazil. • Responsible for managing changes in the business model transition project focused on package with reverse logistics for a logistics operator. • Elaboration and implementation of procedures, according to CBPDA specifications. • Responsible for equipment validation, as well as environment and package qualification. • Responsible for route mapping and risk analysis. • Responsible for ensuring compliance with audits. • Responsible for supporting the Commercial team to meet customer requirements, promoting the choice of technology used in the company. • Implementation of quality practices and compliance with Health Surveillance. • Management of regulatory processes, granting of AFE and license documentation. • Member of the Committees for the implementation of good practices at ANVISA, Pharmaceutical and Cold Chain at ABRALOG. • Responsible for the control of imported products and ensuring the engagement of teams in relation to quality processes. • Implementation of systems to meet the health requirements of RDC 430/2020 and RDC 653/2022 and other current and applicable regulations. • Updating procedures in compliance with the QMS and new operations in Brazil. • Elaboration of non-conformity processes and corrective/preventive action plan. • Monitoring and qualification of suppliers, consultancies and internal, external and regulatory audits. • Customer development through pre and post market analysis. Show less

  • Align Technology
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Quality Assurance Consultant
      • May 2020 - Jul 2021

      • Through consulting, I prepared and adjusted operational documents, by creating work instructions, for the inspection and cleaning process of equipment used in the demonstration and rental process, in order to ensure their integrity in the active return to AlignTech. • Conducted inspections of equipment for integrity at the end of the contract with the customer and return to the logistics operator. • Through consulting, I prepared and adjusted operational documents, by creating work instructions, for the inspection and cleaning process of equipment used in the demonstration and rental process, in order to ensure their integrity in the active return to AlignTech. • Conducted inspections of equipment for integrity at the end of the contract with the customer and return to the logistics operator.

  • GE HealthCare
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Quality Leader | Responsible Pharmacist
      • Jun 2013 - Oct 2019

      • Reporting to the Quality Manager Brazil and Quality Director Latam and responsible for the managemen of the Quality Assurance system, leading 6 people.. • Active member of ANVISA's Best Practices Implementation Committee, together with the implementation of ISO 13485, with several internal awards for performance and results (2014, 2015, 2017, 2018, 2019). • Recall / Stop Shipment for Latin America, without any equipment being unduly released to the customer through daily control and engagement of local logistics teams. • Worked on improving the traceability control of the entire in and out process, from factory to customer installation. • Supporting the installed base team and regulatory team for ANVISA reporting. • Responsible for the flow of control and qualitative coordination of the entire logistics process of product demonstration for Brazil, considering from the request to the return / finalization of the process, considering large events with a weekly movement of approximately five hundred equipment, while small events with weekly handling of approximately thirty equipment with reduction of breakdowns and financial impact. • Conducted non-compliance processes of audits and CAPAs (Corrective Action and Preventive Action). • Designed and implemented project to significantly reduce financial reserves for nonconformities stationary products, reversing inventory impact reserves for inventory turnover gains. • Acted in Internal Purchasing and monitoring of suppliers approved by the Supplier Qualification team. • Monitored internal, external and regulatory audits. • Coordination of pest control, service analysis and trend reporting, control of documents and records, preparation and review of Operating Procedures, actions that meet GMP specifications. • Change Control / Risk Management Coordination. • Worked with the EHS team for the correct disposal of waste according to current rules, highlighting NBR 12235 and NBR 11174 Show less

  • Bio-Rad Laboratories
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Responsible Pharmacist
      • Jan 2012 - Jun 2013

      • Monitoring and analysis of the configuration of temperature control systems for the operational qualification process and guaranteeing the stability of the product. • Worked in maintenance control (preventive and corrective). • Coordinated specific process audits for non-conforming products. • Customer Service. • Monitoring and analysis of the configuration of temperature control systems for the operational qualification process and guaranteeing the stability of the product. • Worked in maintenance control (preventive and corrective). • Coordinated specific process audits for non-conforming products. • Customer Service.

  • Bomi Group
    • Italy
    • Transportation, Logistics, Supply Chain and Storage
    • 700 & Above Employee
    • Quality Coordinator
      • Oct 2009 - Jun 2013

      • Coordination and management of the Quality Assurance system. • Document control, generated records, legal documents (ANVISA, Sivisa / Covisa and CRF), change processes, new projects and Pest Control. • Developed and updated operating procedures (SOPs) for all departments of the company as well as corporate. • Monitoring, analysis, configuration of temperature control systems, operational qualifications and process validations, instrument calibration, development of equipment and area qualifications, process validations and analysis risk impact, analysis of new processes relevant to customers. • Internal and external audit monitoring (clients and regulators). • Coordination, analysis and control of corrective and preventive actions. • Acted in Maintenance control (preventive and corrective). • Customer Service Support and Support. Show less

  • CSL
    • Australia
    • Biotechnology Research
    • 700 & Above Employee
    • Responsible Pharmacist
      • Jan 2009 - Aug 2011

      • Monitoring, analysis, configuration of temperature control systems, operational qualifications process. • Acted in Maintenance control (preventive and corrective). • Coordinated specific process audits for nonconformities products. • Customer Service Support. • Monitoring, analysis, configuration of temperature control systems, operational qualifications process. • Acted in Maintenance control (preventive and corrective). • Coordinated specific process audits for nonconformities products. • Customer Service Support.

  • Drogalessi LTDA
    • São Paulo, Brasil
    • Responsible Pharmacist.
      • Feb 2005 - Jun 2008

      • Performed inventory control, placing purchase orders. • Pharmaceutical assistance for customers. • Dispensing and control of controlled drugs, regulation 344/98. • Regulatory activities with the competent bodies (CRF / COVISA) for authorization of operation and operating license. • Performed inventory control, placing purchase orders. • Pharmaceutical assistance for customers. • Dispensing and control of controlled drugs, regulation 344/98. • Regulatory activities with the competent bodies (CRF / COVISA) for authorization of operation and operating license.

  • Fontovit
    • São Paulo, Brasil
    • Intern
      • Jan 2004 - Jun 2004

      • Document control • Developed and updated operating procedures (SOPs) for all departments of the company. • Monitoring temperature control systems. • Customer Service Support. • Document control • Developed and updated operating procedures (SOPs) for all departments of the company. • Monitoring temperature control systems. • Customer Service Support.

Education

  • Centro Universitário São Camilo
    Bacharelado, Pharmacy
    2000 - 2004
  • FGV - Fundação Getulio Vargas
    GVPEC, Logística Empresarial
    2009 - 2009

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