Senior Quality Assurance Specialist

Job Summary

A company is looking for a Senior Quality Assurance Specialist - CSV in Clinical Research.

Key Responsibilities

• Lead and support Computer System Validation (CSV) activities across clinical systems
• Create, review, and manage validation documents while ensuring compliance with regulatory guidelines
• Participate in audits and contribute to SOP development and risk assessments

Required Qualifications and Education

• Graduate degree in a scientific, medical, or clinical discipline; Master's preferred
• 7-10 years of experience in Computer System Validation (CSV) within clinical research or pharmaceutical domains
• Hands-on knowledge of GAMP 5, GxP, and 21 CFR Part 11 regulations
• Understanding of CROs and related scientific and clinical data
• Exposure to Regulatory Technology (RegTech) or electronic document management systems (EDMS) is preferred