System Validation Specialist

Há 5 dias


São Paulo, São Paulo, Brasil beBeevalidation Tempo inteiro R$80.000 - R$160.000
System Validation Expert

We are seeking an experienced System Validation Expert to join our team. This role requires a strong understanding of regulatory requirements and industry standards for Medical Devices.

  • 7-10 years' experience in Computer System Validation of Regulatory Information Management systems 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 project teams.
  • Experience in drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report.

The ideal candidate will have a solid understanding of SDLC, Jira, xRay, code repository like bitbucket and change control/ management systems like ServiceNow.

Requirements:
  • At least 3 years of experience in system validation.
  • Proven track record of successfully validating complex systems.
  • Excellent communication and interpersonal skills.

Benefits:

This is a great opportunity to work with a dynamic team and contribute to the development of innovative solutions.

Others:

The selected candidate will be required to work closely with the project team to ensure that all tasks are completed on time and within budget.


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