TRD QA Specialist – IT/OT Systems

About the role

Novartis is hiring a TRD QA Specialist for its RLT Colleretto Giacosa Pilot Plant in Ivrea, Italy, an onsite role focused on IT/OT systems. During the pilot plant ramp-up, the specialist provides QA oversight and support for establishing a compliant quality system for GMP-relevant computerized, automated and connected systems, covering qualification, validation, data integrity and lifecycle documentation.

Key responsibilities

• Act as the local QA subject-matter expert for GMP-relevant IT/OT systems, giving independent quality oversight during project ramp-up.
• Review and approve validation and qualification deliverables such as user requirements specifications, risk assessments, validation plans, test protocols, evidence, deviations and summary reports.
• Ensure systems, infrastructure, equipment software, interfaces and data flows are qualified and released before GMP use.
• Define responsibilities among system owners, users, IT, OT, engineering, quality and support functions.
• Oversight of controls for user access, audit trails, electronic records, electronic signatures, backups, business continuity, security and data integrity.
• Review changes, deviations, CAPAs and risk assessments affecting computerized systems, and coordinate periodic compliance reviews.
• Support GxP procedures for validation, access management, audit trails, change control and system retirement, and support internal audits and Health Authority inspections.

Required profile

• Minimum three years of proven experience in pharmaceutical or regulated industry QA, computerized-system validation, laboratory computerized-system support, manufacturing automation, IT/OT quality or a comparable role.
• Familiarity with EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and data-integrity guidance.
• Hands-on experience with IT, OT, computerized or laboratory systems in a regulated environment, and experience preparing, reviewing or approving qualification and validation documentation.
• Ability to understand system architecture, interfaces, data flows, equipment connectivity and electronic records.
• Experience with electronic Quality Systems for change controls, deviations and CAPAs.

Required skills

• Computerized-system validation and qualification
• IT quality and eCompliance
• Operational technology and industrial automation
• Data integrity, electronic records and electronic signatures
• IT infrastructure qualification and system lifecycle management
• Change, deviation and CAPA management
• Quality Management Systems and GxP documentation

What we offer

• Base salary range of EUR 29,800 to 55,300, with a possible performance-based bonus.
• Insurance plans, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working where possible, and at least 14 weeks of paid parental leave.