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Reference # : 17-00334 Title : ****Quality Assurance Lead (Q-CSV)
Location : Edison, NJ
Position Type : Contract
Experience Level : Start Date / End Date : 03/28/2016 / 06/30/2017  
Position Responsibilities: Quality assurance Lead to coach and review deliverables (Q-CSV) for SaaS Project in support of risk based validation. Our client seeks a Senior Quality Reviewer to coach and support a global validation of a SaaS vendor that supports NDA submissions regulatory and quality management. Experience should include the knowledge of risk based validation methodology specifically utilized for SaaS and cloud based hosted platforms; including quality review experience to assess and guide impact to client's QMS (SOPs), project and business. Serve as the QA coach to CSV team and liaison to the business, informatics and IT system owners. Conduct quality review of CSV deliverables including testing protocols. Conduct Q-CSV review pre and post execution of test scripts, SDLC documentation including summary reports, RTM, and change control and other project related deliverables. Review outputs of root cause analysis, resolution and test defect reports (TDRs); work under minimal supervision. Must have strong knowledge of GxP global regulations: FDA, EU, EMEA; Eudralex, ICH, Annex 11, Part 11; GAMP 5; cGXP. Work in close collaboration with Quality management and global cross functional teams. Qualifications & Requirements: 10+ years of Quality assurance, risk assessments, audits, impact assessments, CAPAs and data integrity. Experience should include providing QA guidance for risk based end to end validation of an enterprise hosted SaaS and cloud, compliance with SOPs and global regulations, production of quality CSV and SDLC deliverables. Strong change control experience required. Strong hands on coaching and QA leadership skills required. Knowledge and understanding of latest industry best QA practices as they relates to data Integrity is required. Knowledge and understanding of global GCP regulations, GAMP 5, Part 11, and Annex 11 required. Excellent communication (verbal) and written skills are required.