Senior Analyst

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.