Recognize, exemplify and adhere to ICON’s values which center around our commitment to People,
Clients and Performance.
· As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
· *Travel (approximately 10%) domestic and/or international.
· *Must be able to plan and lead validation and qualification activities for multiple projects, which may be regional or global in scope and are occurring at the same time, ensuring that
the activities conducted are fully compliant with industry regulations and guidelines as required by ICON procedures and the FDA.
· *Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control.
· *Must be able to conduct 21 CFR Part 11 Assessment.
· *Assist Senior Business Analysts in gathering requirements from users and create user/system requirements specification.
– *Create and execute validation deliverables, including but not limited to Validation Plan, Test Scripts, Defect Management, Traceability Matrix, and Validation Summary Report.
-* Perform various types of testing, including but not limited to Black Box Testing, GUI Testing, System Testing, User Acceptance Testing, Functional Testing, and Regression Testing.
· *Must be able to review System Development Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures(SOPs) or Working Procedures (WPs).
· *Must be proficient in related ICON Information Technology SOPs and WPs and possess a
thorough understanding of computer system validation in order to be capable of approving all System Delivery Life Cycle (SDLC) deliverables that are delineated for Validation Team.
· *Assist Senior Business Analysts in gathering requirements from users.
· *Must be able to create, review, and update SOPs and WPs associate with ICON’s SDLC.
· *Must be able to conduct and approve a Periodic Review of computer system validation
documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time.
· *Able to create, update, and present training material associated with all aspects of the System Deliverable Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11, to ICON personnel when needed.
· *Must be capable of representing Validation Team during sponsor audits.
· Focus on meeting project schedules; conducting SDLC, Validation, or Installation Qualification training.
· Keep supervisor and project managers informed of any validation or qualification issues.
· Additional duties as deemed appropriate by the department head/designee.