IT Specialist

• Develop, review, and execute validation documentation, including Validation Plans/Reports, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and test results
• Design and implement validation deliverables, test plans, and test cases based on system understanding and analysis of user, functional, and system specifications
• Maintain new GxP software/computer systems and changes to existing systems in a state of control
• Ensure accuracy and completeness of Software Development Lifecycle and/or IT Validation records
• Collaborate with business users and Business Analysts to understand user requirements and functional design specifications
• Analyze test results and attach evidence to verify acceptance criteria; provide software QA approval for subsequent activities
• Investigate and resolve test case failures and bugs
• Participate in release planning sessions
• Complete protocol, minor change, and lifecycle documentation on time
• Participate in process improvement efforts
• Follow applicable regulatory requirements and company policies and procedures
• Perform other duties as assigned

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