VALIDATION LEAD
Descrição da oferta de emprego
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.
., 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.
., 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
Detalhes da oferta
- Indeterminado
- 20/08/2025
- 12/01/2026
Alinhar as soluções com o time de arquitetura de soluções referência técnica para o time de desenvolvimento de sistemas o realizar quality assurance das soluções para garantir que o desenvolvimento está seguindo as diretrizes dadas na concepção dimensionar, treinar e capacitar tecnicamente o time de......
Experience partnering with hiring managers to build inclusive teams be a team player who’s self-aware, acts with integrity and values diversity demonstrated passion, compassion, and the ability to lead by example horário: comercial salário: salário competitivo com o mercado regime de contratação: clt......
Able to lead and coach by using relationships and influence through others to achieve the business's desired outcome... provide effective guidance and coaching to leaders on hr policies, managing individual and team development and performance to achieve targeted business goals... development of an employee-oriented......
Employee relations management: take the lead in managing complex employee relations issues, ensuring thorough and objective investigations for effective resolution... legal compliance expertise: maintain an in-depth understanding of legal requirements to mitigate risks, collaborating with the legal department......
