
Senior Data Validation Specialist
2 days ago
Job Overview
">The Computer System Specialist will be responsible for managing data platform applications, reviewing and executing test scripts, guiding project teams on deliverables, and applying industry standards and regulations.
">Key Responsibilities
">- Project management of Data Platform applications
- Test script review, test execution review, test defect management
- Guiding project teams on applicable project deliverables
- Application of FDA guidance's and industry standards (i.e., GAMP)
- Understanding of 21 CFR Part 11 and Risk Based Approach
- Drafting and approving CSV deliverables like Compliance Analysis, Compliance Plan, Test Protocol, Test Report and Compliance Summary Report
Required Skills and Qualifications
">- 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
Benefits
">This is a challenging opportunity for experienced professionals to utilize their knowledge and skills in a dynamic environment.
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