Senior Analyst

Job description

Your Role Ensure IT systems and infrastructure meet qualification and compliance standards throughout their lifecycle. Prepare, manage, and maintain qualification documents, including Risk Assessments, Technical Specifications, Installation Qualification Protocols, and Periodic Reviews. Collaborate with Qualification Owners, Process Owners, Compliance stakeholders, and technical teams. Monitor qualification status, track upcoming or overdue activities, identify discrepancies, and coordinate follow-up actions. Drive process improvements that strengthen data quality and regulatory readiness, including qualification-related automation initiatives. Support new project qualification activities, contribute to non-conformance resolution, and act as a key link between technical and compliance functions. Who You Are You hold a bachelor's degree in technical discipline, or an equivalent degree combined with relevant professional experience. You bring a minimum of 5 years of experience in IT Systems or Infrastructure service roles, or in Computerized System Validation (CSV). You have a solid understanding of Computer System Validation principles and GxP-regulated environments, including familiarity with GAMP5 guidelines. You have hands-on knowledge of IT infrastructure technologies, including networks, servers (Windows and Linux), storage and backup solutions, Active Directory, virtualization platforms, cloud environments (AWS, Azure), and databases. You are skilled at preparing and managing qualification documentation using approved templates, coordinating stakeholder review and approval workflows with accuracy and attention to detail. You communicate effectively through technical and compliance teams, building strong working relationships with Qualification Owners and Process Owners to ensure requirements are met. Experience with enterprise or business applications in a regulated environment is an advantage.