Principal Engineer – IT QA & CSV

About the role

We are seeking passionate candidates to join our QA team in Noida, India. Be accountable for reviewing and supporting key CSV deliverables - URS, Validation Plan, Test Plan, Traceability Matrix, Test Summary Report and Validation Summary Reports.

What you'll do

• Organize and ensure accurate and reliable filing for the paper-based GxP documents
• Assist in Quality Investigations and CAPAs
• Support Internal and Client audits on IT-QMS and IT Products
• Provide first level of guidance and support to the project teams on CSV approach required for a planned change to a GxP system
• Participates in internal product audits and supporting external audits

What you need

• 6–11 yrs of experience
• SQL
• Test cases
• Pharmacovigilance
• ISO 9001
• SOP writing
• Agile
• MCA or B.Tech or B.E. or B.Pharm or M.Pharm