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.