Our client is looking for someone with experience in software validation who can work with cross functional teams to generate end to end validation life-cycle deliverables.
Qualifications in the ideal candidate include:
Software Validation expertise.
Knowledge of using risk-based approaches to scale and drive testing.
Working knowledge of GAMP 5 methodology.
Experience generating end to end software validation life-cycle deliverables including – User Requirements, GxP Applicability / Part 11 Assessments, Validation Plans, Functional Risk Assessments, Test Plans, Test Summary Reports, Traceability Matrices and Validation Final Reports.
Work independently and complete/validate a system within given constraint of scope, time and schedule.
Excellent verbal communication and writing skills.
Experience with IQ, OQ, PQ, testing and Defect Management.