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System Validation Expert
2 semanas atrás
System Validation Expert
">We are seeking a highly experienced system validation expert to lead computer system validation projects. The ideal candidate will have in-depth knowledge of regulatory requirements, specifically FDA guidelines and industry standards (GAMP), as well as 21 CFR Part 11 and Risk Based Approach.
">The successful candidate will have the ability to guide project teams on regulatory compliance, draft and approve CSV deliverables such as Compliance Analysis, Compliance Plan, Test Protocol, Test Report, and Compliance Summary Report. They will also have a solid understanding of SDLC, Jira, xRay, code repository like Bitbucket, and change control management systems like ServiceNow.
">The System Validation Lead will be responsible for:
">- Leading computer system validation projects
- Drafting and approving CSV deliverables
- Guiding project teams on regulatory compliance
- Maintaining knowledge of industry standards and regulations
The ideal candidate will possess:
">- 7-10 years of experience in system validation
- In-depth knowledge of FDA guidelines and industry standards
- Experience with SDLC, Jira, xRay, Bitbucket, and ServiceNow
This is a unique opportunity to work on complex system validation projects and contribute to the success of our organization. If you are a motivated and experienced professional looking for a new challenge, please apply now.
