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Validation Specialist

Id: AT0097


  • ·       Perform Validation Assessment on customized and off-the-shelf clinical trial data processing systems in compliance with the applicable FDA Regulations that are 21CFRPart11 and 21CFRPart820.

    ·       Perform GxP Functional Risk Assessment on customized clinical trial applications.

    ·       Author System Design and Master Validation Plan documents for the customized applications.

    ·       Author User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)/ User Acceptance Testing (UAT), Traceability Matrix, Deviation/ Exception reports and Validation Summary Report (VSR) documents for the customized and off-the-shelf systems using a Validation Lifecycle Management System (VLMS) software.

    ·       Periodic Review and Audit Trail/ Data Integrity Review of different customized and third-party systems to analyze any gaps or non-compliance with the regulations and standard operating procedures.

    ·       Perform Root Cause Analysis for Quality incidents and involved in the preparation of CAPA (Corrective Action and Preventive Action) reports to ensure compliance with established procedure.

    ·       Create Test Plans and perform functional and regression testing during various phases of test lifecycle throughout the Defect Tracking and Resolution cycles.

    ·       Implement automation testing of GxP computerized systems including identifying and implementing tools, setup of testing, documentation, approval, and delivery.

    ·       Follow GAMP5 practices for authoring and reviewing Validation Documentation.

    ·       Support product innovation by developing novel and creative software validation processes in an Agile environment.


    This position requires a minimum of a Bachelor’s degree in Pharmaceutical Science or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.