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Compliance Lead

5 months ago

King of Prussia, United States Talent Groups Full time

Job Description:

Roles and Responsibilities – Compliance Lead

  • 10years’ Experience in Validating SAP systems in Manufacturing
  • Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems.
  • Perform review for GxP systems to ensure compliance with regulatory requirements.
  • Working knowledge on end-to-end validation of GxP applications and can perform document/process Compliance Analysis
  • Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology.
  • Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability.
  • Ensures Risk Assessment is completed for all the requirements and test cases are designed in reference to the risk levels identified for the requirements.
  • Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness, and appropriateness of the test case to the requirement.
  • Ensures pre-executed test protocol has the necessary test data requirements to run the tests.
  • Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process.
  • Able to author Validation Plan and compile Validation Summary Report and generates RTM.
  • Reviews and ensures that the Operational Procedure for the application is ready.
  • Can handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM
  • Prior experience in using tools like ALM, DMS and JIRA
  • Good to have experience in implementing US-DSCSA