IDI Consulting is Hiring a Validation Expert for S4HANA Near Foster, CA
Job Details
Support of creating and maintaining GxP (GMP, Google Cloud Platform, GLP) quality and compliance environment for SAP S/4 HANA 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
Draft the OQ & PQ test scripts for the GxP requirements and E2E GxP test scenarios
Support overall protocol executions, log and track defects
Review the executed test protocols for the proper documentation of test results and evidence
Review the defects for proper documentation per the checklist
Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested
Prepare and approve qualification summary report
Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release
Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials
“IDI Consulting LLC is an Equal Opportunity Employer M/F/V/D”