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Senior Validator
3 semanas atrás
The ideal candidate will have 7-10 years of experience in Computer System Validation, with a strong understanding of FDA guidance and industry standards (GAMP). They should be familiar with 21 CFR Part 11 and Risk Based Approach, and have the ability to guide project teams. Additionally, they should have experience drafting and approving CSV deliverables such as Compliance Analysis, Compliance Plan, Test Protocol, Test Report, and Compliance Summary Report.
Key Responsibilities:
- Apply a solid understanding of SDLC, Jira, xRay, code repository like Bitbucket, and change control/management systems like ServiceNow.
- Draft and approve CSV deliverables.
- Guide project teams on regulatory compliance.
Requirements:
- 7-10 years of experience in Computer System Validation.
- Strong understanding of FDA guidance and industry standards (GAMP).
- Familiarity with 21 CFR Part 11 and Risk Based Approach.
- Experience with SDLC, Jira, xRay, Bitbucket, and ServiceNow.
- Ability to draft and approve CSV deliverables.
