02 ott - Ivrea
Novartis Italia
Summary
Location: Ivrea, Italy #onsite
Role Purpose
During the Pilot Plant ramp-up and operationalization, provide QA oversight and support for the establishment of a compliant quality system for GMP-relevant IT, OT, computerized, and automated systems. The role focuses on system qualification and validation, data integrity, lifecycle documentation, procedures, interfaces, equipment connectivity, and ongoing compliance.
The QA Specialist will support the implementation and qualification of computerized systems used in manufacturing, QC laboratories, facilities, utilities, and supply-chain processes. In routine operations, the role ensures that these systems remain compliant, fit for intended use, and maintained in a validated state throughout their lifecycle.
Hiring a QA Specialist with IT/OT expertise for the TRD RLT Colleretto Giacosa Pilot Plant is essential to establish local Quality capability for IT/OT system qualification, procedure development, and initial manufacturing-line validation.
The role requires hands-on experience with computerized systems in pharmaceutical or regulated environments, strong knowledge of quality assurance and data-integrity principles, and effective collaboration with all the stakeholders.
About The Role
Major Accountabilities
• Act as the local QA subject-matter expert for GMP-relevant IT/OT systems, providing independent quality oversight while supporting cross-functional execution during project ramp-up.
• Review and approve key validation and qualification deliverables, including User Requirements Specifications, risk assessments, validation plans, test protocols, executed test evidence, deviations, and qualification or validation summary reports.
• Ensure that global applications, locally configured systems, infrastructure components, equipment software, interfaces, and data flows are appropriately assessed, qualified, and released before GMP use.
• Ensure clear definition of responsibilities among system owners, system
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