Support IS Quality role on global IT projects and applications.
Project support would include guiding validation and testing strategy, reviewing and approving key project documents (e.g. validation plan, requirements, design, testing, reports….).
Application support would include guiding change controls including impact assessments, change plans and test plans. Reviewing and approving change controls and implementation documentation against previously approved change plans.
Support other IS Quality activities as requested (e.g. periodic review, Part 11 compliance audits, training)
Computer Validation, Change Management, System Development Life Cycle