RESPONSIBILITIES: Onsite Validation Lead for SAP 12-15 years of Computer system Validation Experience. - 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.
Review Test Summary Reports and get the approval from Customer Quality Team. •
Last updated on Aug 22, 2022