GBIT Inc. is a staffing and recruiting company.
Supports the computer system validation process by ensuring alignment of operations with system requirements, corporate policies, industry standards, and applicable regulations. This individual will also lead in gathering business requirements, identifying gaps in the software, conducting effective risk assessments, evaluating mitigation strategies, execution of validation testing, defect resolution and completion of validation deliverables. The individual should be a good team player with excellent communication. motivation, team building and mentoring skills with the ability to work independently and in rapport with Business Analysts, Functional Leads, End-users, Quality and Project Managers.
Assists in the development, planning, directing and tracking of the validation of computer systems supported by the IS/IT team.
Expertise in all phases of Software Development Life Cycle (SDLC) and Computer System validation (CSV)
Works with the project teams to develop validation strategies for projects and works closely with project managers and program managers to meet the deadlines.
Leads the technical and business analysis team members to ensure compliance with system requirements, corporate quality standards, HIPAA guidelines and FDA regulations (21 CFR part 11, Annex 11 and/or 820).
Maintains production computer systems in a regulatory compliant state, monitors all modifications or changes to systems or processes, initiates change control / revalidation as required and ensures a continual state of inspection readiness with regard to validation guidelines.
Coordinates project activities which includes, but not limited to developing project plans, kick off presentations, sending communication plans, establishing risk mitigation strategies and identifying crucial success factors for the deployment of the project.
Generates/revises Validation Master Plans (VMP), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessments (RA), and Final Summary Reports (VSR) by providing instructions and scientific rationale for the performance of validation studies.
Coordinates the testing efforts of the IS/IT and business teams with regards to requirements, resource planning, test coverage and test strategies.
Works in parallel with the business SMEs and IS Applications staff to create thorough, accurate and comprehensive test scripts.
Develops, maintains and executes validation test scripts, test metrics and generates reports for management use in determining project and applications test status and coordinates testing schedule with IS/IT team.