Compliance consultant Job at Katalyst Healthcares & Life Sciences, Boonton, NJ

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  • Katalyst Healthcares & Life Sciences
  • Boonton, NJ

Job Description

Responsibilities:


  • Lead the development and execution of validation protocols for SAP implementation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).


  • Create comprehensive validation strategies and summary reports to document the qualification process and results for the SAP platform.


  • Review and provide guidance on test scripts and testing guidelines to ensure thorough and compliant SAP system testing.


  • Collaborate with cross-functional teams to understand GxP business requirements and prioritize them in the validation process.


  • Assess and ensure that the SAP system meets SOX/Financial controls and high-level testing requirements, maintaining compliance with all relevant regulations.


Requirements:



  • Proven experience in computer system validation with a focus on SAP implementation.


  • Strong understanding of GxP requirements and the ability to integrate them into the validation process effectively.


  • Knowledge of SOX/Financial controls and the ability to ensure that testing meets these high-level requirements.


  • Demonstrated ability to develop validation protocols and summary reports, ensuring comprehensive coverage and compliance.


  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams and stakeholders.

Katalyst Healthcares & Life Sciences

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