GxP Validation Specialist (Warsaw)

Opis oferty

Xebia is a global AI-first, digital transformation, and engineering partner. With over 25 years of experience and a team of 5,000 professionals across 16 countries, we help organizations design and build scalable products, platforms, and data-driven solutions. 

We specialize in Artificial Intelligence, Data and Cloud, Intelligent Automation, and Digital Products, combining deep technical expertise with a strong focus on engineering excellence and a people-first culture.  

In the CEE region, we’re a team of nearly 1,000 experts delivering modern applications, data platforms, and AI solutions for clients such as Millennium, ING, Play, Edenred, Arabian Drilling, FedEx, Leroy Merlin, Truecaller, Volotea, Schmitz Cargobull, and many, many more. We work with leading technologies including AWS, Azure, GCP, Databricks, and Snowflake, and combine strong engineering culture with a consulting mindset and a continuous focus on growth and knowledge sharing. 

Wymagania

• 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 operate effectively in cross-functional teams.
• Strong attention to detail and regulatory compliance requirements.
• Work from the European Union region and a work permit are required.

Zakres obowiązków

• Leading and supporting GxP validation activities for the data platform.
• Co-authoring validation and qualification documentation, including SOPs and validation deliverables.
• Preparing and maintaining qualification documentation and traceability records.
• Contributing to risk assessments and validation planning activities.
• Supporting creation and execution of IQ (Installation Qualification) and OQ (Operational Qualification) protocols.
• Preparing qualification reports and validation evidence.
• Supporting validation activities performed within regulated systems and documentation repositories.
• Ensuring platform changes are assessed and managed through formal change-control processes.
• Supporting requalification activities triggered by platform configuration changes.
• Collaborating with platform engineers, architects, data engineers, quality teams, and business stakeholders.
• Providing validation oversight for regulated data products, transformations, and reporting solutions.
• Supporting inspection readiness, audit support, and compliance-related activities.
• Participating in knowledge-transfer and operational handover activities.