
System Validation Specialist
3 days ago
In this role, you will play a crucial part in ensuring data platforms are validated to meet regulatory requirements.
- Develop comprehensive knowledge of CSV creation, revision, and documentation.
- Manage Data Platform applications project management, test script review, test execution review, and test defect management.
- Apply industry standards (e.g., GAMP) to ensure compliance.
- Guide project teams on 21 CFR Part 11 and Risk-Based Approach.
Required Skills:
- System Validation
- Test Case Review, Validation Plan, Validation Summary Report
- Regulatory Compliance
- Validating SAP, ERP, LIMS, Data Platforms
- GAMP Guidelines, Industry Standards
What We Offer:
- A challenging role with opportunities for growth and development.
- Collaborative team environment.
- Flexible work arrangements.
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