
Validation Lead
3 semanas atrás
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
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