Role: QA Lead – IT Operations (IT QC SME)
Location: Hyderabad

Summary
The IT QA Subject Matter Expert (SME) will serve as the primary expert and point of contact for quality‑related computerized systems, including Veeva DMS, Veeva QMS, Veeva RIM, Cornerstone, TrackWise, OpenText DMS, and QC laboratory systems such as CDS Empower, Moda EM, WinKQCL, Tiamo, and SoftMax Pro. This role ensures that these systems are designed, maintained, and operated in compliance with GxP, data integrity principles, and internal quality standards. The SME will provide L3 support, manage enhancements, oversee projects, and ensure lifecycle management. Partnering closely with QA, QC, IT, and business stakeholders, the SME will guide regulatory compliance, support audits, drive continuous improvement, and ensure quality processes are fully and accurately supported by IT systems.

Key Accountabilities
- Serve as system SME for QA and QC IT systems, providing expert guidance on functionality, compliance, and best practices.
- Provide L3 support, manage enhancements, projects, and lifecycle activities.




- Support quality system processes (document management, training, change control, deviations, CAPA, laboratory operations) through configuration oversight, governance, and troubleshooting.
- Ensure GxP compliance and data integrity across all assigned systems, including validation documents, change controls, periodic reviews, and audit trails.
- Partner with QA, QC, and IT teams to assess system changes, upgrades, and enhancements, ensuring compliance impacts are fully managed.
- Develop, review, and maintain SOPs, work instructions, and procedures related to system use, data integrity, and lifecycle management.
- Ensure compliance with Lonza’s validation framework and relevant global, local, and industry regulations.
- Contribute to the evolution and implementation of Lonza’s roadmap for applications, operations, and services.
- Provide training and guidance to end users and stakeholders to

📌 QA Lead – IT Operations (Hyderabad)
🏢 Lonza
📍 Hyderabad