Job Code : BSA-19-0030
Positions : 1
Job Type : Full Time
Location : New York, USA
Key Skills :
4 years ago
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.