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 current 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.

📌 Senior Analyst (Bengaluru)
🏢 The businesses of Merck KGaA, Darmstadt, Germany
📍 Bengaluru