Hello Guys
Role: Validation Analyst
Rate: : $50/hr on c2c
Location:Mansfield MA( local only ) need photo ID
Client: Confidential
Visa: noH1B CPT and TN
Duration: 6 months
Qualifications:
Must Have
We are looking for a pure validation resource withperiodic review audit experience.
8 yearsExperience in Validating GxP applications
Experience in FDA and/or Global regulated environment withgood understanding of Google Cloud Platform GLP and Risk basedvalidation strategy
Provides consultation andcounseling on Risk and Compliance module implementation inreference to regulatory quality
Support Riskassessment
Document Regulatory Requirements andReview Specification documentation (viz. User Stories URSFRS)
Review and final Approval of requirementsTechnical Design and Solution Architecture Plan IQ OQ and PQ preand post execution documents
Lead Write Review/Approve Discrepancy Logs (final dispositions)
Lead Write Review / Approve Requirement TraceabilityMatrix (RTM) and Validation Summary Reports