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Validation Lead for SAP/ PM

Negotiable
Full-time
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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

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