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Senior It Business Analyst – Edms And Qms

hace 2 meses


Barcelona, España Galderma A tiempo completo

.Job Title: Senior IT Business Analyst – eDMS and QMSLocation: BarcelonaJob DescriptionWe are looking for a Senior IT Business Analyst with expertise in electronic Document Management Systems (eDMS) and Quality Management Systems (QMS) to join our team. In this role, you will play a crucial part in ensuring our document and quality management systems meet both business and regulatory requirements. The ideal candidate will have extensive experience in IT solutions for document and quality management within a regulated environment, such as pharmaceuticals, biotech, or medical devices.Key ResponsibilitiesRequirements Gathering and Analysis for eDMS and QMSCollaborate with business stakeholders to gather, analyse, and document functional and technical requirements for eDMS and QMS systems.Translate business needs related to document lifecycle management, quality control, and compliance into clear, actionable IT specifications.System Implementation and OptimizationLead or support the implementation of eDMS and QMS solutions, ensuring alignment with business goals, industry standards, and regulatory requirements.Propose and drive optimization initiatives for existing document and quality management systems to enhance efficiency, usability, and compliance.System Validation and ComplianceEnsure all eDMS and QMS systems meet regulatory standards such as GxP, ISO, and 21 CFR Part 11.Lead system validation activities, including user acceptance testing (UAT) and creation of validation documentation.Stakeholder Management and CommunicationServe as the primary liaison between IT, quality assurance, regulatory, and business units to ensure eDMS and QMS solutions meet all stakeholder requirements.Facilitate workshops, meetings, and presentations to align stakeholders on project goals, timelines, and system capabilities.Process Mapping and Continuous ImprovementAnalyse and document current document management and quality control processes, identifying areas for improvement.Recommend and implement process changes leveraging eDMS and QMS solutions to enhance productivity, compliance, and audit readiness.Vendor and Solution EvaluationEvaluate and select appropriate eDMS and QMS vendors, considering business requirements, industry standards, and system compatibility.Manage relationships with external vendors and consultants to ensure timely delivery of solutions.Data Migration and System IntegrationLead or support data migration efforts, ensuring a smooth transition from legacy systems to new eDMS and QMS platforms.Ensure integration of eDMS and QMS with other enterprise systems such as ERP, LIMS, and CRM.Training and SupportDevelop training materials and lead training sessions for end-users to ensure proper utilization of eDMS and QMS systems.Provide ongoing support for business teams in troubleshooting and optimizing system performance.Project ManagementCoordinate IT projects within the clinical development area, ensuring timely and within-budget delivery