Senior Validation Specialist

Há 6 dias


São Paulo, São Paulo, Brasil beBeeValidation Tempo inteiro R$90.000 - R$120.000
Job Description:

Our organization is seeking a seasoned professional with 7-10 years of experience in computer system validation, specifically in the realm of regulatory information management systems used in medical devices. The ideal candidate will possess a deep understanding of FDA guidelines and industry standards, such as GAMP.

Key Responsibilities:

  • Develop and approve compliance deliverables, including analysis, plans, test protocols, reports, and summaries
  • Guide project teams on risk-based approaches and 21 CFR Part 11 regulations

Required Skills:

  • Familiarity with Software Development Life Cycle (SDLC), JIRA, X-rays, code repositories, and change control/management systems
Benefits:

This is an exciting opportunity to leverage your expertise in validation and regulatory affairs while contributing to our team's success.


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