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Validation Lead
Ref No.: 18-00932
Location: Baskin Ridge, New Jersey
Position Type:Contract
Experience Level: 11 Years
Start Date / End Date: 11/15/2018 to 03/29/2019
Position Responsibilities
Sr. Computer Systems Validation Lead.


Our client seeks a strong hands on computer systems validation project lead to support a global validation of a SaaS system. Experience should include risk based validation methodology utilized for SaaS and cloud based hosted platforms.
  • Serve as the validation subject matter expert and liaison to the business, IT system owners, and Quality Liaison.
  • Conduct a GxP risk and impact assessment.
  • Author validation plan, functional requirement specs and validation deliverables
  • Author/Review OQ PQ testing protocols and manually execute test scripts, SDLC documentation including summary reports, RTM, and change control.
  • Work with the vendor for configuration management
  • Conduct root cause analysis for test defects and resolution.
  • Assume a leadership role and take ownership of project related tasks, work under minimal supervision. Interface with vendor and coordinate new releases.
  • Strong knowledge of FDA and GxP global regulations: Annex 11 and Part 11 and good clinical practices cGCP.
  • Setup and facilitate tactical and strategic meetings with key stakeholders (Business System Owners, CSV Quality Assurance, Systems Users, etc.) and vendor
  • Report to and work in close collaboration with client management.
  • Complete assigned project artifacts on schedule.
Qualifications & Requirements:
  • 10+ years of CSV experience including leading a risk based end to end validation of an enterprise hosted cloud based system.
  • Experience with validating drug safety systems and PV systems preferably ARGUS or in support of a utility upgrade which provides integration between Oracle Argus and Medidata's Rave.
  • Authoring, reviewing, and executing test protocols; producing quality CSV deliverables. Strong change control experience required.
  • Strong hands on leadership skills.
  • Knowledge and understanding of latest industry data Integrity trends are required.
  • Knowledge and understanding of global cGxP regulations, GAMP 5, Part 11, and Annex 11 required.
  • Excellent communication (verbal) and written skills are required.
  • Gap analysis skills.