JOB DUTIES: Perform end-to-end validation activities of various GxP systems. Facilitate and document regulatory risk assessment. Ensure validation processes are performed according to the organization’s policies, procedures, and directives. Provide guidance on validation approach, tasks, and deliverables based on risk. Author, review, and/or approve validation deliverables per applicable procedures, including the execution of formal, validated system test and User Acceptance Testing (UAT) phases of each release. Ensure validation deliverables are maintained in designated electronic repositories in a well-organized fashion, and available for inspection. Liaise with IT Quality services during vendor due diligence activities. Liaise with business unit and quality/compliance functions to ensure regulatory requirements are well understood and documented. Ensure infrastructure is appropriately qualified. Ensure validated systems are maintained in a state of control. Collaborate with IT staff and business partners to support internal and external regulatory inspections. Foster the adoption of standards and tools that facilitate quality and compliance. Apply FDA and other applicable global regulations to the development of computer systems supporting regulated business processes. Deliverables shall include Software Development Lifecycle (SDLC) and validation deliverables for specific projects which include: user and functional requirements, Validation plan, GxP applicability assessment, risk assessment forms, Performance Qualification script, Traceability matrix, summary reports, exception or deviations. Ensure product and process development activities have all necessary validation and supporting justification.
REQUIREMENTS: Master’s degree in Technology, Computer Science, Information Technology, MIS or a closely related field. 3 years using GxP systems. 2+ years User Acceptance Testing (UAT), following FDA regulations, standards and guidance. 2+ years end-to-end validation activities including CP,IQ, OQ and PQs.
Application instructions: To apply, please apply online at vensaiinc.com/careers or share your CVs to [email protected].
Pay: $76,399.34 - $92,007.80 per year
Benefits:
Work Location: Hybrid remote in Cumming, GA 30040
