GxP Validation Specialist (Warsaw)

The role

You will lead and support GxP validation activities for a data platform. You will write validation and qualification documents, run IQ and OQ protocols, and manage change control and requalification.

What you will do

• Lead and support GxP validation activities for the data platform
• Co-author validation and qualification documentation, including SOPs
• Prepare and maintain qualification documentation and traceability records
• Contribute to risk assessments and validation planning
• Support creation and execution of IQ and OQ protocols
• Prepare qualification reports and validation evidence
• Ensure platform changes go through formal change-control processes
• Support requalification triggered by platform configuration changes
• Provide validation oversight for regulated data products and reporting solutions
• Support inspection readiness, audits and compliance activities

Required qualifications

• Experience working in GxP-regulated environments
• Hands-on experience with computer system validation (CSV) or equivalent validation frameworks
• Experience creating and maintaining validation and qualification documentation
• Knowledge of IQ/OQ execution and qualification reporting
• Understanding of change control, risk assessment and validation lifecycle management
• Familiarity with SOP creation and maintenance
• Experience working with quality and compliance stakeholders
• Strong documentation, communication and organizational skills
• Ability to work effectively in cross-functional teams
• Strong attention to detail and regulatory compliance requirements

Nice to have

• Experience validating cloud-based platforms and data solutions
• Experience with Databricks or modern data platforms
• Familiarity with validation management tools such as Kneat
• Experience supporting GxP analytical or reporting environments
• Knowledge of data governance and regulated data processing practices
• Experience in large-scale data modernization or migration programs
• Understanding of platform qualification automation and evidence-as-code approaches
• Experience supporting audits, inspections or regulatory reviews

Before you apply

• Work from the European Union region and a work permit are required
• Recruitment process: CV review, HR call, interview, client interview, decision

About the company

Xebia is a global AI-first digital transformation and engineering partner with over 25 years of experience and 5,000 professionals across 16 countries. In the CEE region it has nearly 1,000 experts working on AI, data and cloud solutions for clients.