GMP IT/OT QA Specialist – System Validation Lead (Ivrea)

IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl; Ivrea; In loco; EUR 30.000 - 55.000; Tempo pieno

Vantaggi offerti da questo lavoro

Performance bonus

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

Parental leave 14 weeks

Descrizione del lavoro

Novartis in Ivrea, Italy is seeking a QA Specialist to support GMP-relevant IT/OT and computerized systems. The role focuses on qualification, validation, data integrity, and lifecycle documentation across manufacturing, QC labs, and utilities.

Responsibilities include reviewing validation deliverables, ensuring proper system ownership, and maintaining audits, deviations, and CAPAs to support compliant operations.

Competenze

• Minimum of three years in pharmaceutical or similar regulated industry in QA, computerized-system validation, or IT/OT quality.

Mansioni

• Provide QA oversight for GMP IT/OT systems and computerized systems.
• Review validation/qualification deliverables (URS, risk assessments, validation plans, test protocols, evidence).
• Ensure systems are qualified, released, and maintained in a validated state.

Conoscenze

QA oversight

IT/OT expertise

Data integrity

Regulatory compliance

Cross-functional collaboration

GxP documentation

Change control

Strumenti

Validation tools

Audit readiness tools

Descrizione del lavoro

Novartis in Ivrea, Italy is seeking a QA Specialist to support GMP-relevant IT/OT and computerized systems. The role focuses on qualification, validation, data integrity, and lifecycle documentation across manufacturing, QC labs, and utilities.

Responsibilities include reviewing validation deliverables, ensuring proper system ownership, and maintaining audits, deviations, and CAPAs to support compliant operations.