GxP Validation Specialist

Quick Facts

• Role: GxP Validation Specialist

• Focus: GxP validation for a data platform in regulated environments

Description

Lead and support GxP validation activities for the data platform, including co-authoring validation and qualification documentation (SOPs, protocols, reports) and maintaining traceability records. Execute and support IQ/OQ protocols, contribute to validation planning and risk assessments, and manage platform changes through formal change control. Support inspection readiness, audits, and compliance-related activities, collaborating with engineering and quality stakeholders.

Responsibilities

• Lead and support GxP validation activities for the data platform

• Co-author validation and qualification documentation (SOPs and validation deliverables)

• 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

• Support validation activities within regulated systems and documentation repositories

• Ensure formal change-control for platform changes

• Support requalification triggered by platform configuration changes

• Collaborate with platform engineers, architects, data engineers, quality teams, and business stakeholders

• Provide validation oversight for regulated data products, transformations, and reporting solutions

• Support inspection readiness, audit support, and compliance activities

• Participate in knowledge transfer and operational handover

Requirements

• Experience 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

• Ability to work from the EU region with a work permit

Benefits

Not specified in the provided posting.