Job Description :
COMPUTER SYSTEMS VALIDATION CONSULTANT
u>Services/u>
Consultant will assist with Computer Systems Validation (CSV) consulting support. Tasks as requested by include:
ul>
li>Ensure compliance with internal and external GxP system policies and regulations/li>
li>Perform validation of GxP and non-GxP systems and collaborate with teams in making critical decisions with respect to validation/li>
li>Conduct Periodic Reviews per applicable policies and procedures to ensure that the computer systems maintain their validated status./li>
li>Track validation projects and provide updates on the progress to Management/li>
li>Gather User Requirements and author validation deliverables/li>
li>Facilitate risk management and maintain required controls to ensure system security/li>
li>Prepare and maintain training material and ensure the personnel involved in projects are adequately trained/li>
li>Ensure proper documentation, testing, communication and stakeholder management for system changes/li>
li>Participate in audits and inspections and provide the needed documentation to demonstrate validation state and proper management of the systems though the life- cycle./li>
li>Author, review and approve documents including validation deliverables, protocols and reports/li>
li>Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report/li>
/ul>