Job Description
We are offering an exciting opportunity for a Computer Systems Validation Specialist in New Haven County, Connecticut. As part of our team, you will be instrumental in ensuring adherence of computer systems used in regulated industries to the requisite industry standards and regulatory requirements. This role involves a broad range of responsibilities, from the planning and execution to the documentation of validation activities for software systems.
Responsibilities
• Develop validation plans, protocols, and summary reports for computer systems to ensure regulatory compliance and quality standards are met
• Identify critical aspects of systems that impact product quality or patient safety through risk assessments and gap analyses, ensuring compliance with GxP regulations
• Manage the entire System Development Life Cycle (SDLC) of computer systems, ensuring validation is integrated at each stage
• Create and execute test protocols for system verification, documenting and resolving any discrepancies or deviations
• Oversee system changes through a controlled change management process, ensuring that modifications maintain compliance with validation and regulatory requirements
• Ensure validation activities are thoroughly documented, including user requirements, functional specifications, test cases, results, and validation reports
• Serve as a subject matter expert during regulatory audits and inspections, providing validation documentation and explaining strategies and processes to auditors
• Provide training to team members and stakeholders on validation requirements and best practices, while staying updated on regulatory changes and emerging industry trends.
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