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