Validation Lead

3 semanas atrás


São Paulo, São Paulo, Brasil Decision group Tempo inteiro

Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report Solid understanding of SDLC, Jira, xRay, code repository like bitbucket and change control/ management systems like ServiceNow Habilidades: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk Based Approach with the ability to guide the project teams Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report Solid understanding of SDLC, Jira, xRay, code repository like bitbucket and change control/ management systems like ServiceNow

Formação Acadêmica:

Não informado

Salário:

A combinar

Cargo:

Outros

Empresa:

Decision group

Atua com consultoria de mão de obra de serviços de tecnologia.

Ramo:

Recursos Humanos/ Recrutamento e seleção

(EE)
  • Validation Specialist

    1 dia atrás


    São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$93.100 - R$121.110

    Our organization is seeking an experienced Validation Specialist to lead the validation of computer systems in medical devices applications. The successful candidate will be responsible for ensuring compliance with FDA guidelines and industry standards such as GAMP. About the Role:The Validation Lead will work closely with cross-functional teams to plan,...

  • Validation Expert

    Há 5 dias


    São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$80.000 - R$150.000

    Job Title: Validation LeadA high-level validation professional is sought after to lead computer system validation projects. The ideal candidate will possess extensive experience in validating regulatory information management systems used in medical devices.7-10 years' experience in Computer System ValidationStrong understanding of 21 CFR Part 11 and Risk...

  • Validation Specialist

    2 semanas atrás


    São Paulo, São Paulo, Brasil GWM Brasil Tempo inteiro

    **Validation Engineer Specialist****Job Mission**Ensure robust validation for new projects to Brazilian market, attending program needs and key project milestones.As a team, contribute to define and clarify the validation processes aligned with headquarters, generate engineering solutions, reports and develop team members.**Main Responsibilities**Define and...


  • São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$120.000 - R$140.000

    System Validation Expert">We are seeking a highly experienced system validation expert to lead computer system validation projects. The ideal candidate will have in-depth knowledge of regulatory requirements, specifically FDA guidelines and industry standards (GAMP), as well as 21 CFR Part 11 and Risk Based Approach.">The successful candidate will have the...

  • Validation Lead

    Há 5 dias


    São Paulo, São Paulo, Brasil Decision group Tempo inteiro

    Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...

  • Validation Lead

    Há 6 dias


    São Paulo, São Paulo, Brasil Decision group Tempo inteiro

    Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...

  • Validation Lead

    Há 4 dias


    São Paulo, São Paulo, Brasil Decision group Tempo inteiro

    Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...

  • Validation Lead

    2 semanas atrás


    São Paulo, São Paulo, Brasil Decision Group Tempo inteiro

    Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...

  • Validation Lead

    Há 5 dias


    São Paulo, São Paulo, Brasil Decision group Tempo inteiro

    Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...

  • Validation Lead

    1 semana atrás


    São Paulo, São Paulo, Brasil Decision group Tempo inteiro

    Nível Acadêmico: Ensino Superior Completo Turno/Horas -- Áreas de Atuação Profissional: TI - Projetos Descrição: 7- 10 years' experience in Computer System Validation of Regulatory Information Management system used in Medical Devices Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and Risk...