GMP IT/OT QA Specialist — Onsite Ivrea, Italy

Novartis Italia; Ivrea; On-site; EUR 30,000 - 55,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Hybrid working options

Job summary

Novartis Italia seeks a QA Specialist with IT/OT expertise for the Ivrea Pilot Plant to provide QA oversight and support for GMP-relevant computerized systems, qualification, validation, and data integrity across IT/OT, manufacturing and QC settings.

You will review validation deliverables, manage lifecycle documentation, ensure regulatory compliance, and work with cross-functional teams to sustain a validated state and robust QA processes.

Qualifications

• Minimum of three years of proven QA or qualified IT/OT experience in pharma or regulated industry.
• Familiarity with EU GMP Annex 11, 21 CFR Part 11 and data-integrity guidance.
• Hands-on experience with IT/OT computerized systems used in regulated environments.
• Strong quality mindset and cross-functional collaboration ability.

Responsibilities

• Act as local QA SME for GMP-relevant IT/OT systems and support ramp-up.
• Review and approve validation/qualification deliverables and reports.
• Ensure systems are qualified, released, and maintained in a validated state.
• Define responsibilities among system owners, IT/OT, Quality, and other teams.

Skills

GxP knowledge

Data integrity

IT/OT quality

Computerized-system validation

Quality Assurance

Tools

EU GMP Annex 11

21 CFR Part 11

GAMP 5

Job description

Novartis Italia seeks a QA Specialist with IT/OT expertise for the Ivrea Pilot Plant to provide QA oversight and support for GMP-relevant computerized systems, qualification, validation, and data integrity across IT/OT, manufacturing and QC settings.

You will review validation deliverables, manage lifecycle documentation, ensure regulatory compliance, and work with cross-functional teams to sustain a validated state and robust QA processes.