Computer Systems Quality Assurance(CSQA)

Computer Systems Quality AssuranceThis Computer Systems Quality Assurance role will be responsible for supporting the expansion of client's ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards.Key Objectives/DeliverablesMaintain Inspectional ReadinessEnsure supported systems are validatedEnsure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plansParticipate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understoodEnsure all Inspection Readiness materials are current and appropriateDeliver Projects, Programs, and SupportProvide consulting and interpretation on client processes as related to the supported computer systemProvide training to customer areas on CSV-related topics as neededPartner with Business, Business Quality, and IT customer areas to deliver business valueUnderstand customer, company, and Quality prioritiesReview/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completedEngage customers and QA management in appropriate discussions of risk managementEnsure suppliers of computer systems or services meet quality expectationsEscalate computer system quality issues to the appropriate personsStrive for and promote consistency within the CSQA OrganizationStreamline and Continuously ImproveEliminate non-value-added activities in order to focus on activities which continuously improve assurance of qualityIdentify opportunity for streamlining and simplification and assist in developing improved solutionsUnderstand external trends and potential ramifications for the supported IT area(s)