Sr IT Computer System Validation Specialist
George Konik Associates - Minneapolis, MN

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Experienced IT Computer System Validation Specialist needed to focus on SDLC processes and document development as well as infrastructure/hardware qualifications.

This position is responsible for ensuring that GxP regulated computer systems are in compliance with regulatory requirements, company policies and procedures.

Responsibilities :
  • Provide compliance leadership, direction and oversight to project teams in SDLC document development and maintenance.
  • Lead the development and execution of SDLC documentation including Risk Assessments, User Requirements and Configuration Specifications.
  • Participate in developing and approving documentation for: Gap Assessments, System Validation Master Plans, IQ/OQ/PQ, System Validation Final Reports, Trace Matrices.
  • Lead the development and execution of IT Infrastructure Qualifications


Qualifications :
  • Bachelor’s degree in IT or Engineering
  • Professional certification or training/ experience in Information Systems (IS)/Technology related compliance within an FDA, EMEA, GMED or TGA regulated industry
  • A minimum of five (5) years experience performing/ supporting Computer System Validations (CSV).
  • Experience in SDLC management.

Julie Desmond



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