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IT Quality Expert 

Purpose

To ensure the quality and regulatory compliance of the computerized system, related IT operations and IT suppliers. The role supports validation and qualification activities throughout system maintenance and development, including change control, deviation management, periodic reviews, while maintaining audit readiness.

Scope

• Contribute to the IT Management System maintenance and continuous improvement
• Provide product management support for validation and qualification activities
• Ensure IT supplier quality and compliance aligned with internal standards
• Support audit readiness and remediation activities in IT environment
• Operate in an international environment with cross-functional collaboration

Key Tasks

• Prepare and maintain validation documentation, including validation plans, risk assessments, requirements traceability, and validation reports
• Assess the validation impact of system changes and coordinate updates to affected deliverables
• Prepare and review validation test cases and support controlled validation test execution
• Support investigations of validation deviations and track related CAPA actions
• Perform scheduled periodic reviews of validated systems
• Collaborate with cross-functional teams to ensure compliant product development
• Maintain audit readiness and provide evidence for audit scoping and planning
• Proactively identify risks, evaluate audit and inspection findings, monitor remediation and action plans
• Support Quality Assurance Agreements with suppliers.
• Train teams on compliance and documentation standards.

Working Relations

• Team members and Team Leader
• System Owners, Process Managers, internal clients and cross-functional IT and non-IT teams, external IT Service Providers
• Internal and external auditors

Qualifications

Soft Skills

• Passion for quality, compliance, and technology
• Attention to detail and focus on accuracy and completeness
• Strong communication and collaboration skills
• Ability to work across cultures and global teams
• Strong organizational skills and ability to manage multiple tasks
• Willingness to learn and develop skills
• Ability to train and share knowledge with others

Hard Skills

• University degree in IT, natural sciences, or related field
• Approx 5 years of experience in computerized system validation (CSV) or IT Quality assurance for regulated industries
• Knowledge of GxP environment, preferably in the GCP area, and risk-based validation practices
• English proficiency at B2/C1 level
• Advanced Microsoft Office skills (Excel, Word, PowerPoint)
• Experience with software development, agile environment and digital collaboration tools (Teams, SharePoint, Jira, AzureDevOps)
• Basic knowledge of document management and validation lifecycle systems
• Familiarity with audit, risk, change, or deviation management (beneficial)
• Exposure to Veeva Vault products, Clinical Data management systems, or cloud-based integration and data platforms is an advantage