IT QA Senior Expert

The role includes the following responsibilities to support services offered by Global Operations:

• Provide validation support for IT projects by reviewing and approving validation deliverables from a Quality perspective, including specifications, test plans, test results, and change controls.
• Support system lifecycle activities by creating, reviewing, and maintaining validation documentation in compliance with GxP and internal standards.
• Ensure data integrity (ALCOA+) is embedded in system design, implementation, and operation.
• Collaborate with IT, Quality, and Business stakeholders to ensure alignment on validation and compliance expectations.
• Support complex system implementations and upgrades, applying a risk-based approach to validation and compliance.
• Contribute to the development and maintenance of validation procedures, templates, and strategic documentation.
• Provide informal guidance and training to project teams and stakeholders on validation practices, regulatory expectations, and internal policies.
• Actively contribute to the continuous improvement and knowledge sharing within the IT Q&C team and across the organization.

The role also includes the following responsibilities to support services offered by the IT Q&C department:

• Support internal and external audits (regulatory, customer, supplier) and ensure audit readiness.
• Contribute to the global supplier qualification process by reviewing validation and compliance documentation.
• Support the management and maintenance of procedures, guidelines, and training materials.
• Assist in infrastructure qualification and inventory management activities.
• Participate in IT Q&C process improvement initiatives.

• Bachelor s or Master s degree in Information Technology, Life Sciences, or a related field.
• Minimum of 3 years of professional experience in Computer System Validation (CSV) or SDLC activities in a GxP-regulated environment.
• Experience in IT system implementation, particularly in QC and EDMS domains.

• In-depth knowledge of GxP compliance requirements from EMA, FDA, and other relevant regulatory bodies.
• Strong understanding of risk-based validation and compliance approaches.
• Proven experience in CSV within regulated environments.
• High attention to detail and results-oriented mindset.
• Excellent command of English (written and spoken).
• Strong interpersonal, communication, and presentation skills.
• Ability to work effectively in a global, cross-functional team environment.