
Validation Specialist
Há 14 horas
Our organization is seeking an experienced Validation Specialist to lead the validation of computer systems in medical devices applications. The successful candidate will be responsible for ensuring compliance with FDA guidelines and industry standards such as GAMP.
About the Role:
The Validation Lead will work closely with cross-functional teams to plan, execute, and document validation activities. They will be responsible for developing and implementing validation strategies that meet regulatory requirements.
Key Responsibilities:
- Lead the validation of computer systems used in medical devices applications
- Ensure compliance with FDA guidelines and industry standards (i.e., GAMP)
- Develop and implement validation strategies that meet regulatory requirements
- Guide project teams to draft and approve 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
Requirements:
- 7-10 years' experience in Computer System Validation of Regulatory Information Management systems used in Medical Devices
- Strong understanding of 21 CFR Part 11 and Risk-Based Approach
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