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Contract ::::: Validation Expert for S4/HANA at Foster City, CA

2 months ago

San Mateo, United States JS Consulting Full time
Job DescriptionJob Description

Job Title: Validation Expert for S4/HANA
Location: Foster City, CA
Duration: 12+ Months
Interview: Webex

Job Description-:

Primary Skills:

  • Excellent communication (oral and written) and attention to detail
  • 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects
  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
  • Excellent knowledge of GxP regulations, FDA and EMEA guidelines including 21 CFR Part 11
  • Excellent knowledge of computer system validation and GAMP -5 standards

Description:

  • Support of creating and maintaining GxP (GMP, GCP, 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