
System Validation Expert
1 day ago
Job Summary:
We are seeking an experienced System Validation Expert to join our team. As a key member of our organization, you will be responsible for ensuring the accuracy and reliability of our computer systems.
Key Responsibilities:- Validate system functionality and ensure compliance with industry standards
- Develop and implement testing plans to verify system performance
- Collaborate with cross-functional teams to identify and address system issues
- Analyze data to inform business decisions and drive process improvements
Required Skills and Qualifications:
- 4-20 years of experience in system validation, Agile methodology, and multiple release management
- Extensive knowledge in CSV auditing, creation, and revision of documentation
- Experience with Data Platform applications project management, test script review, test execution review, and defect management
- Application of FDA guidance's and industry standards (GAMP)
- Strong understanding on 21 CFR Part 11 and Risk Based Approach
Benefits:
- Drafting and approving CSV deliverables like Compliance Analysis, 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, and change control/management systems
Others:
- The ideal candidate should possess strong system validation skills
- Familiarity with GAMP Guidelines, GxP Guidelines, and Industry Standards
- Knowledge of 21 CFR part 11 and experience in validating SAP, ERP, LIMS, and Data Platforms
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