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 ensure compliant system use.
- Support audits and inspections, acting as system expert to provide evidence, documentation, and explanations of system controls.
- Drive continuous improvement initiatives to optimize quality processes, strengthen controls, and enhance usability and compliance.
- Perform other duties as assigned.
Requirements
Education & Experience
- Bachelor’s degree in Computer Science, Life Sciences, or related field (preferred).
- 4+ years of hands‑on experience with QA/QC systems (Veeva DMS, Veeva QMS, Veeva RIM, Cornerstone, TrackWise, OpenText DMS, CDS Empower, Moda EM, WinKQCL, Tiamo, SoftMax Pro).
- Strong understanding of GxP principles, data integrity (ALCOA+), FDA 21 CFR Part 11, Annex 11, and QA/QC processes.
- Familiarity with quality systems such as change control, deviations, CAPA, training management, and document control.
- Knowledge of CSV concepts and system lifecycle management (GAMP 5) is a strong plus.
- Exposure to laboratory operations, QC workflows, and LIMS or integrated lab systems is desirable.
Skills & Competencies
- Understanding of QA/QC systems architecture, workflows, and configuration.
- Knowledge of GAMP 5, FDA 21 CFR Part 11, ALCOA+ and data integrity principles.
- Excellent documentation and communication skills.
- Experience in IQ/OQ test case development and execution.
Soft Skills
- Ability to work under time pressure and manage multiple priorities effectively.
- Strong problem‑solving and analytical thinking.
- Proactive in identifying and troubleshooting potential issues.
- Team‑oriented with excellent collaboration and interpersonal skills.
- Ability to contribute to business strategy and transformation roadmaps.
- Business fluent in English.
About Lonza
At Lonza, our people are our greatest strength. With more than 30 sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values—Collaboration, Accountability, Excellence, Passion, and Integrity—reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. Lonza is committed to creating an inclusive environment for all employees.
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