SAP Validation Lead

Job description

Job Requirements: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Skills: - Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system - Perform GxP and 21 CFR part 11 assessments and develop validation plan - Develop functional risk strategy and perform functional risk assessment - Review user business process documents and user requirements specification - Review functional, technical and configuration design documents - Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols - Review the test scripts for the requirements and test scenario coverage - Lead overall protocol executions, log and track defects - Review the executed test reports for the proper documentation of test results and evidence - Review the defects for proper documentation per the checklis...