SAP Validation Lead - California City - RxCloud

    RxCloud
    RxCloud California City

    2 days ago

    $1,000,000 - $1,200,000 (USD) per year
    Description

    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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