Descrição de Vaga
| Código: | 14836 |
| Título da vaga: | Validation Lead |
| Local: | São Paulo, SP |
| Nível Profissional: | Analista |
| Nível Acadêmico: | Ensino Superior Completo |
| 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: | Período de 3 a 6 meses na vaga. |