Principal Engineer – IT QA & CSV
NoidaFull-time6–11 yrsPosted 1 week ago
Senior quality assurance role at RxLogix Corporation in Noida. Needs 6+ years and an MCA, B.Tech or B.E..
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
- SQL
- Test cases
- Pharmacovigilance
- ISO 9001
- SOP writing
- Agile