SAP Validation Lead

1 day ago

California City, CA, United States RxCloud Full time

About the job SAP Validation Lead

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.

  • 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 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
  • Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
  • Maintain overall project and issue tracker and report routinely
  • 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
  • Maintain day to day activities status tracker and report routinely
  • Lead the team of validation engineers located in different time zones
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
  • Team management

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