Validation Lead

Description

The Product Hold/Recall Management Validation Lead will drive the validation aspects of the project required to qualify the new Track wise Platform Infrastructure and validate the Product Hold/Recall Management workflow system within that platform. This system will be used to manage data collected on Baxter product holds and recalls. Purpose of the Position Act as Validation Lead for the infrastructure and application aspects of the Track wise Product Hold/Recall Management project. The infrastructure will be built and qualified, after which the new workflow will be configured and validated for product hold/recall functionality. Critical Job Responsibilities 1. Generate Master Plan, Infrastructure Qualification Plan/Protocol, Validation Plan, Qualification Protocol(s), Test Plans, Risk Assessments, Reports, and Trace Matrix. 2. Participate in and guide team in generating/modification of Infrastructure Design, User Requirements, Functional and Design Specifications. 3. Gain understanding and follow defined SDLC. Ensure quality validation processes are executed as defined by procedures. 4. Using riskbased approach to validation, determine testing, documentation and verification activities, with appropriate justification of the approach. 5. Deploy strategy, defining documentation requirements for the aspects of the infrastructure, base system and workflow(s) with Track wise. 6. Manage electronic routing of required documentation