GMP IT/OT QA Specialist — Systems Validation & Compliance

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

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Parental leave

Job summary

Novartis Ivrea is seeking a QA Specialist to provide QA oversight for GMP-relevant IT/OT and computerized systems during ramp-up, focusing on system qualification, validation, data integrity, and lifecycle documentation.

You will ensure compliant operation of IT/OT systems in manufacturing and labs, support audits and inspections, collaborate across IT, OT, Quality, and operations, and help establish local quality capability for IT/OT qualification and initial manufacturing-line validation.

Qualifications

• Minimum of three years in pharma or regulated industry.
• Hands-on experience with validated IT/OT systems.
• Knowledge of data integrity and QA processes.

Responsibilities

• Provide QA oversight for GMP IT/OT systems during ramp-up.
• Review and approve validation deliverables and deviations.
• Ensure GMP release for global/local IT/OT applications.
• Support audits and inspections related to computerized systems.

Skills

Quality Assurance

GxP compliance

IT/OT quality

Data integrity

System lifecycle

Validation documentation

Cross-functional

Audits support

Tools

EU GMP Annex 11

21 CFR Part 11

GAMP 5

Job description

Novartis Ivrea is seeking a QA Specialist to provide QA oversight for GMP-relevant IT/OT and computerized systems during ramp-up, focusing on system qualification, validation, data integrity, and lifecycle documentation.

You will ensure compliant operation of IT/OT systems in manufacturing and labs, support audits and inspections, collaborate across IT, OT, Quality, and operations, and help establish local quality capability for IT/OT qualification and initial manufacturing-line validation.