IT Validation Lead – GxP Data Migration

💻 Ework Group - founded in 2000, listed on Nasdaq Stockholm, with around 13,000 independent professionals on assignment - we are the total talent solutions provider who partners with clients, in both the private and public sector, and professionals to create sustainable talent supply chains. With a focus on IT/OT, R&D, Engineering and Business Development, we deliver sustainable value through a holistic and independent approach to total talent management. By providing comprehensive talent solutions, combined with vast industry experience and excellence in execution, we form successful collaborations. We bridge clients and partners & professionals throughout the talent supply chain, for the benefit of individuals, organizations and society. 🔹 For our Client we are looking for IT Validation Lead – GxP Data Migration 🔹 Are you an experienced IT Validation Lead with a strong background in GxP validation, data migration, interfaces and supplier assessment? Do you want to take validation responsibility for a large-scale migration from a legacy platform to a new regulated IT solution and help ensure that the migration and related integrations are compliant, controlled and fit for intended use? ✔️ What you will be doing: This is a job for those who are excited to work with technologies, validation, testing and quality control in agile IT projects. The main responsibility will be to lead validation activities for a large-scale GxP data migration, while also supporting validation of interfaces and supplier assessments. We expect you are ready to: Own and drive GxP validation activities for the migration from a legacy system to a new regulated IT solution Define and maintain the migration validation approach, including validation plans, risk assessments, test documentation, reports and traceability Support definition and verification of the migration process, including data mapping, transformation rules, reconciliation, completeness and accuracy checks, exception handling and migration evidence Plan, coordinate and execute migration testing together with business representatives, developers, IT QA, Process QA and other relevant stakeholders Assess and validate interfaces and integrations between regulated IT systems, including data transfer controls, error handling, reconciliation and interface testing Perform or coordinate GxP supplier assessments and evaluate supplier documentation and controls as input to the validation approach Manage validation deviations, defects, risks and follow-up actions through resolution and documented closure Work independently as Validation Lead, take responsibility for validation deliverables and participate as the validation expert in large-scale IT projects in Development ✔️ Core competences: Strong experience in IT Validation within pharma or another regulated industry, with the ability to lead validation activities independently Hands-on experience with validation of GxP data migrations, including data mapping, transformation, reconciliation, migration testing and migration reporting Experience with validation of system interfaces and integrations, including APIs or other automated data transfers and related control mechanisms Experience with GxP supplier assessment, including evaluation of supplier capabilities, quality processes, documentation and validation evidence Strong knowledge of GxP, data integrity, risk-based validation, quality processes and risk identification, with a quality-focused mindset Degree in Computer Science, Engineering, Software Development, Life Sciences or a related field Experience with large-scale projects and agile methodologies; familiarity with Azure DevOps, test management and test automation is advantageous Skilled in stakeholder management and communication, ensuring timely involvement of key stakeholders such as LoB, IT QA, Process QA, Business Owners, Architects, IT Security and suppliers Promotes a healthy and collaborative working environment and is comfortable driving tasks, decisions and follow-up across multiple teams ✔️ We offer: B2B agreement Transparent working conditions with both Ework and the client Current support during our cooperation Possibility to work in an international environment Collaborative environment in Swedish organizational culture Private medical care Life insurance Multisport Teambuilding events Contact person: karolina.rosikiewicz@eworkgroup.com Client code: HN04/MM03 Do you know someone who would fit this position? Recommend a candidate by sending her/his CV to: polecenia@eworkgroup.com Whistleblowing Policy, which provides guidelines for reporting misconduct can be found on Ework website: https://www.eworkgroup.com/about-us/our-responsibility