
System Validation Specialist
2 days ago
The ideal candidate will have experience in computer system validation of data platform applications, Agile methodology, and multiple releases in parallel.
Key Responsibilities:
- Develop extensive knowledge in CSV creation and revision of CSV documentation.
- Manage Data Platform applications project management, test script review, test execution review, and test defect management.
- Guide the project team with applicable project deliverables based on project type and category while catering to the SDLC.
- Apply FDA guidelines and industry standards (i.e., GAMP).
- Understand 21 CFR Part 11 and Risk Based Approach and guide the project teams.
- Draft Compliance Analysis, Compliance Plan, Test Protocol, Test Report, and Compliance Summary Report.
- Be familiar with procedures, work instructions, forms, and templates.
- Have solid understanding of SDLC, Jira, QTest, automated test tools, code repository like Bitbucket, and change control/management systems like ServiceNow.
Required Skills:
- Computer System Validation
- Test Case Review, Validation Plan, Validation Summary Report
- 21 CFR part 11
- Validating SAP, ERP, LIMS, Data Platforms
- GAMP Guidelines, GxP Guidelines, Industry Standards
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