Computer System Validation

Keywords Computer System Validation, CSV, GxP, 21 CFR part 11, Risk Based Approach Roles and Responsibilities 10 yrs. of experience in Computer System Validation Senior Level individual with GxP experience Ability to lead, fully knowledgeable of Agile based System development process Exhibits strong knowledge and hands-on experience in Agile concepts and applies AGILE approach in using tools like JIRA, X-ray/qTest Handles and maintains projects in JIRA along with burn charts, manage time and backlog Fully knowledgeable of the Regulated Quality Processes (GxP assessment, CSV Assessment)., etc. and application of Risk Based Approach in system development and change management process Review and approves applicable project related artifacts to ensure regulatory quality Adept in handling Change Management of Computerized systems Efficient in Quality Management related to GxP regulations. Primary & Secondary Skill: Computer System Validation Required, 10 years' experience in CSV only thus I need resource for more than 10 years. Must have skills - CSV, GxP, 21 CFR part 11, JIRA, X-RAY