QA GCP, Inspection Readiness Contractor

Description Provide support and expertise on R&D QA activities (GCP, GLP, GVP, GcLP) inspection readiness and preparation. Including but not limited to Create the readiness plan, oversee the project, create and update processes and SOPS, reviewing documents, help create narratives and storyboards. Experience Inspection Readiness. Should be a GCP SME that has done SOP committee work, experience with PV is a plus. Responsibilities Lead and participate as a QA SME expert and manage SOP committee deliverable/operations for R&D functions – ICH E6(R3)R3 Updates and inspection readiness. Need to support activities, schedule and should be a GCP SME that has done SOP committee work, also suggest a part Inspection Prep activities – Run Core Team meetings, schedule meetings and complete participate as an SME in readiness plan Develop/edit Policies, SOPs in compliance with best practices Update and review Clinical Quality Agreements for high priority studies Manage and organize deliverables Update the QA Plans for all studies to meet phase and industry standards Develop formal Audit Schedule for all studies that includes vendors and site audit planned and any IR audits Support for all clinical studies including QA to QA meetings Provide and participate in R&D QA training activities – General and Inspection Readiness and associated topics. Including but not limited to Issue Management/Risk Management Training, Storyboard training Create and run R&D QA Quality Forum and R&D QMR plan and schedule Familiarity with AVOCA Key Skills Inspection preparation activities (at least 3 prior inspection preparation cycles-including mock inspections, interview preparation, SOP review, documentation review, storyboarding, clinical site preparation activities, and review of metrics) GCP SME that has done SOP committee work, experience with PV is a plus Previous experience in clinical inspections including but not limited to hosting, serving as liaison or as interview preparation for SMEs- at least 3 clinical inspections in this capacity. Previous experience in project management, prior experience with project management of inspection preparation preferred #J-18808-Ljbffr Planet Pharma