Validation Expert
2 days ago
Validation Lead
About the RoleWe 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.
- 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.
- 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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