Computer System Validation Auditor (GAMP 5 Focused)

Location: Remote 

Experience: 4-8 years 

Shift timing: 7:30 PM to 4:30 AM IST  

About the role: 

We are looking for a skilled Computer System Validation (CSV) Auditor with strong expertise in GAMP 5 Second Edition, FDA Computer Software Assurance (CSA), and risk-based validation methodologies. The candidate will be responsible for assessing computerized systems, conducting validation and compliance audits, evaluating supplier validation practices, and ensuring systems comply with global regulatory requirements throughout their lifecycle. 

Key Responsibilities: 

• Assess computerized systems to determine GxP impact, validation applicability, and system criticality. 

• Perform risk-based assessments and validation applicability reviews using GAMP 5, ICH Q9, FMEA, and 

criticality assessment methodologies. 

• Conduct independent audits of computerized systems, va...