
Data Platform Expert
5 days ago
Job Opportunity
We are seeking a highly skilled Computer System Specialist to join our team.
- Key Responsibilities:
- Proficient in computer system validation of data platform applications, including data lakes, data warehouses, and data bricks.
- Experience with agile methodologies and handling multiple releases in parallel.
- Strong knowledge of CSV, CSV auditing, creation, and revision of CSV documentation.
- Expertise in data platform applications project management, test script review, test execution review, and test defect management.
- Guidance on project deliverables based on project type and category while catering to the software development lifecycle.
- Application of FDA guidelines and industry standards, such as GAMP.
- Understanding of 21 CFR Part 11 and risk-based approaches with the ability to guide project teams.
- Experience in drafting and approving CSV deliverables like compliance analysis, compliance plan, test protocol, test report, and compliance summary report.
- Familiarity with procedures, work instructions, forms, and templates.
- Strong 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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