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Job Description CSV Specialist Version Date: March 2023 Reporting to: IT Compliance Director Brief Position Description: As part of Novotech ITC department, the Computer System Validation Specialist is responsible for leading GxP Compliance and testing strategies across GxP applications and GxP support systems to guide all platform team leads/ SME’s on UAT planning and execution. Education and Experience: ? Degree in a science or information technology related discipline with a minimum of 5 years of relevant experience in GxP CSV projects. ? Experience or background in highly regulated industries such, healthcare, pharma, or biotech industry is desirable. Skills and Competence: ? End to end understanding of regulatory guidelines including understanding of risk-based validation approach. ? Strong working knowledge of 21 CFR Part 11, Anenxure-11, Validation, SDLC and Change Management processes. ? Audit experience on IT systems (GxP and Non GxP). ? SOP and template authoring experience. ? Experience in executing IT projects using different methodologies (i.e., waterfall, agile etc.) ? Exposure to ETL technologies and Reporting tools like PowerBI is preferred. Responsibilities: ? The CSV Specialist acts as primary point of contact for all validation aspects of GxP applications and works with system owners, Clinical Systems team, QA team, Business Operation teams to maintain CSV compliance. ? The CSV Specialist will define validation/testing roadmap for GxP applications and systems, including risk assessment planning, execution, and authoring validation documents. Strategize and plan UAT testing along with application team leads/SME’s. ? Author and review SDLC/CSV documentation such as Validation/Test plan, User Requirement Specifications, Process Flows, Design Specifications, Requirement Traceability Matrix, Test Cases, Test Scenarios, etc. ? In consultation with key stakeholders for relevant GxP projects, prepare time and resource estimates for project deliverables related to SDLC/UAT testing. ? Review/publish system test reports, defect summary report, perform defect analysis and drive defect to closure. ? Authoring/reviewing IT Periodic evaluation reports with respect to GxP systems, user setup and configuration management. ? Liaise with respective teams regarding change management activities associated with IT applications and actively participates in Change Approval Board (CAB) meetings. ? Identify and report any quality or compliance concerns and take immediate corrective action as required. ? Assist in Quality Investigations, vendor audits, system audits and CAPA preparation. ? Guide IT/Clinical Systems team on the CSV impact for all the change controls & best practices. ? Provide support for routine compliance checks and RFP responses. ? Conduct CSV trainings for team members and keep them abreast on latest development in CSV requirements. ? Remain abreast of new developments in the CSV domain and suggest improvements to drive efficiencies that benefit Novotech as well as client services. ? Understand company processes in areas relevant to SDLC and CSV and be quality minded in performance of duties. ? Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.