Validation Lead

4 weeks ago


King of Prussia, United States Talent Groups Full time

Must Have Skills: CSV, SAP Validation, Product Serialization, DSCSA

Roles and Responsibilities – Regional System Assurance Lead

  • 10years’ Experience in Validating SAP systems in Manufacturing
  • Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems.
  • Perform review for GxP systems to ensure compliance with regulatory requirements.
  • Working knowledge on end-to-end validation of GxP applications and can perform document/process Compliance Analysis
  • Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology.
  • Able to author Validation Plan and compile Validation Summary Report and generates RTM.
  • Can handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM
  • Prior experience in using tools like ALM, DMS and JIRA



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