Validation Lead for SAP/ PM

• Extensive knowledge in GAMP 5, 21 CFR Part 11 compliance
• Experience in driving key strategic programs from Planning to execution of Validation activities.
• Good knowledge SAP S4 system.
• Understand Requirement from SMEs/Business team.
• Involve in GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting.
• Ensure timely completion of all testing activities as per the project plan.
• Perform estimation and get it approved from validation manager for new requirements/Scope change for all validation work.
• Assists in analysis of requirements for testability, accuracy, and in assessment of requirements risk and getting clarifications raised by offshore test team.
• Defines the Validation test strategy and plan.
• Manage test progress and quality against entrance/exit criteria.
• Review of Validation test deliverables and ensure the completion on time and get it approved from business stakeholders and Quality and Compliance team.
• Reporting testing status on weekly basis to Validation Manager.
• Manages defect tracking and resolution of defects.

Last updated on Aug 22, 2022