
Computer System Validation Specialist
Há 19 horas
Job Description:
We are seeking a seasoned expert in computer system validation to join our team. As a key player, you will be responsible for ensuring the compliance of our Regulatory Information Management system used in Medical Devices with FDA guidelines and industry standards (i.e., GAMP). You will leverage your strong understanding of 21 CFR Part 11 and Risk Based Approach to guide project teams and deliver high-quality CSV deliverables.
Required Skills and Qualifications:
- 7-10 years' experience in Computer System Validation
- Strong understanding of FDA guidance's and industry standards (i.e., GAMP)
- Excellent knowledge of SDLC, Jira, xRay, code repository like bitbucket and change control/ management systems like ServiceNow
- Able to draft and approve Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report
Benefits:
- Opportunity to work on challenging projects in a dynamic environment
- Collaborative team atmosphere with opportunities for growth and development
- Competitive compensation package
Others:
- This is a unique opportunity to work with a leading company in the field of Medical Devices
- Be part of a team that values innovation, collaboration, and continuous improvement
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