
System Validation Expert
9 hours ago
We are seeking a highly skilled computer system specialist to join our organization.
About the RoleThis is an exciting opportunity for experienced professionals who have a deep understanding of computer system validation and agile methodology. The ideal candidate will have experience in handling multiple releases in parallel and will be able to guide project teams with applicable project deliverables based on project type and category.
Responsibilities- Develop extensive knowledge of CSV auditing, creation, and revision of CSV documentation.
- Experience with data platform applications project management, test script review, test execution review, test defect management.
- Apply FDA guidelines and industry standards (i.e., GAMP).
- Strong understanding of 21 CFR Part 11 and risk-based approach with the ability to guide project teams.
- Draft and approve CSV deliverables like compliance analysis, compliance plan, test protocol, test report, and compliance summary report.
We are looking for candidates with strong technical skills, including:
- 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
Please note that only qualified candidates will be contacted for further evaluation.
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