Global Computer Systems Validation Specialist

at  GE Healthcare

JOB DESCRIPTION SUMMARY

The Global Computer Systems Validation Specialist is responsible for coordinating and ensuring the execution of risk and regulatory IT compliance-related tasks for non-commercial products and processes. This role will support and manage tasks which impact the GEHC PDx organization. This role reports directly to the Pharmaceutical Diagnostics (PDx) Validation Manager within the Global Quality Compliance Team.
The global GxP computerized systems within the GE HealthCare (GEHC) Pharmaceutical Diagnostics (PDx) business must be maintained in a validated state to comply with GEHC’s PDx Quality Management System (QMS) and ensure audit readiness for Health Authority and Regulatory Agency inspections. This role will support or manage projects related to the lifecycle management of existing computerized systems and the implementation of new technologies.
New computer systems must adhere to a formal Computer Systems Validation (CSV) process, which governs key tasks and deliverables related to requirements gathering, design, build, testing, implementation, and retirement. This role is responsible for overseeing all these activities, as well as managing formal change processes for all PDx Global GxP Computer Systems.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree.
• Strong communication skills.
• Good project management and prioritisation skills; ability to effectively manage multiple tasks and priorities.
• Well versed with the ISPE GAMP 5 Guide.
• Experience with Application Lifecycle Management (ALM) testing tool desirable.

• Maintain GxP software compliance and support operational processes.
• Ensure computerized systems meet current Data Integrity and Part 11 requirements, as applicable.
• Participate in internal and external audits, ensuring systems are audit-ready.
• Perform and/or support risk analysis and impact assessments as part of the validation process.
• Work with the Quality, Integrated Supply Chain (ISC), & project team members to ensure supporting validation tasks are completed within the defined timelines, & according to pre-defined criteria.
• Partner with peers to suggest & implement process improvements for business operation & process execution.
• Design and support regulatory compliance processes as assigned and respond to requests for assistance from IT & business teams.
• Assist in transformational activities for the regulatory compliance function, as assigned by leadership.
• Execution of Test Management - including authorship of Validation Plans, Test Plans, Test Report, Validation Reports, & review of test scripts.
• Support and/or oversee formal change management processes for validated systems.
• Conduct CSV Supplier Assessments for proposed vendors as necessary.
• Manage the lifecycle of computerized systems, including updates, upgrades, and retirement.
• Provide technical support and training on validation processes and relevant standard operating procedures.