SAP GRC Controls/SOX Validation Specialist

JSR Tech Consulting
Raritan, NJ Contractor
POSTED ON 5/18/2022 CLOSED ON 11/2/2022

What are the responsibilities and job description for the SAP GRC Controls/SOX Validation Specialist position at JSR Tech Consulting?

JSR has an immediate  opening for an SAP GRC Controls specialist with experience implementing SOX compliance in a GXP environment.

 


REQUIREMENTS :
  • Candidate must have deep hands on  experience with SAP GRC controls.Will be working on the adaption, launching and control management of SAP GRC.
  • Implementing automation for SOX compliance.
  • Translate complex requirements for implementation to the team
  • Provide examples to build controls and define them
  • Provide an end to end view of getting  in place and monitoring
  • Making sure the system is designed  for preventative controls – catch things before they happen.
  • Ensuring that the quality of application controls is in place to support business and patient safety.
  • GXP experience (especially with gxp, manufacturing, distribution controls.)
  • Understanding of how gxp/ sox controls work together
  • Should have experience with Controls for manufacturing in an ERP system. Setting up controls relating to batch release and assuring only the QA team can release that batch. Should have experience with distribution controls that automatically put that returned item or product directly and automatically into Quarantine after being scanned in. How would you go about this and what controls would you use ?
  • Ability to provide examples of IT GC's (general computer controls) and integrity in GxP.
  • Provide an example of when you took controls and implemented them.
  • Be able to give examples to build controls and define them
  • Provide an end to end view of framework in place and monitoring

Regulations needed and additional skills:
  • Knowledge of regulations such as 21 CFR part 11, 820, 211, 210, etc. is definitely a plus
  • Iso 13485 is desired
  • Knowledge of GxP framework and good practices needed
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