Data Platform Specialist
3 days ago
A system specialist is sought after to drive the validation and implementation of data platforms.
About the Role- The ideal candidate will have extensive knowledge in CSV auditing, creation, and revision of CSV documentation.
- Experience with data platform applications project management, test script review, test execution review, and test defect management is required.
- Guide the project team with the right set of deliverables based on project type and category while catering to the SDLC.
- Apply FDA guidance's and industry standards (i.e., GAMP).
- Understand 21 CFR Part 11 and guide the project teams using a risk-based approach.
- Draft and approve compliance analysis, compliance plan, test protocol, test report, and compliance summary report.
- Familiarity with procedures, work instructions, forms, and templates.
- Solid understanding of SDLC, Jira, QTest, automated test tools, code repository like bitbucket, and change control/management systems like ServiceNow.
- Computer System Validation
- Test Case Review, Validation Plan, Validation Summary Report
- 21 CFR part 11
- Validating SAP, ERP, LIMS, Data Platforms
- GAMP Guidelines, Industry Standards
We offer competitive benefits and opportunities for professional growth.
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