Validation Expert

2 days ago


Rahway, New Jersey, United States Tekfortune Inc Full time
Job Title

Validation Lead

About the Role

We are seeking an experienced Validation Lead to join our team at Tekfortune Inc. As a key member of our validation team, you will be responsible for ensuring that our SAP systems and associated healthcare applications meet regulatory and operational requirements.

Key Responsibilities
  • Develop and execute comprehensive Computer System Validation (CSV) plans, protocols (IQ, OQ, PQ), and reports.
  • Ensure compliance with healthcare industry regulations, including FDA 21 CFR Part 11, GxP, and HIPAA.
  • Collaborate with cross-functional teams to define validation requirements and implement risk-based validation strategies.
  • Perform detailed validation activities, including system testing, user acceptance testing (UAT), and documentation of test results.
Requirements
  • Strong expertise in Computer System Validation (CSV) processes and methodologies.
  • Proficiency in validating SAP systems and associated healthcare applications.
  • In-depth knowledge of healthcare regulatory compliance, including HIPAA and other industry standards.
  • Experience in risk-based validation approaches, focusing on critical system functionalities.
What We Offer
  • An estimated salary of $120,000 - $180,000 per year.
  • A dynamic and supportive work environment.
  • Ongoing training and professional development opportunities.


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