GxP & System Validation Expert

Role Overview

An exciting opportunity exists for an experienced professional to support ERP Cloud migration activities within a regulated Life Sciences and manufacturing setting. This position emphasizes the importance of Computer System Validation, GxP compliance, and setting validation strategies to ensure that all migration and deployment activities align with regulatory and quality standards.

Key Responsibilities

• Define and execute validation strategies for ERP Cloud migration activities, adhering to CSV and GxP requirements.
• Ensure all ERP migration and implementation processes comply with relevant regulatory requirements and standards.
• Develop and maintain comprehensive validation documentation throughout the project lifecycle.
• Support system qualification, risk assessments, validation planning, and execution for successful outcomes.
• Coordinate and oversee validation testing activities, including the review and approval of test evidence.
• Ensure effective traceability between requirements, risks, testing, and validation deliverables.
• Support audit readiness, ensuring that all documentation is thorough and inspection-ready.
• Collaborate closely with business, Quality, QA, IT, and technical teams during testing and deployment phases.
• Identify validation and compliance risks, implementing appropriate mitigation strategies.
• Provide expert guidance on GxP expectations throughout the ERP migration and system implementation processes.
• Assist with deployment and go-live activities from a validation and compliance standpoint.

Key Skills & Experience

Essential:

• Proven experience in Computer System Validation (CSV).
• Strong understanding of GxP and regulated Life Sciences environments.
• Experience in defining and executing robust validation strategies.
• Background in ERP implementation or Cloud migration projects.
• Solid knowledge of risk assessments, qualification, testing, and validation documentation.
• Experience collaborating with Quality/QA, business, and technical stakeholders.
• Strong documentation capabilities and audit-readiness experience.
• Ability to operate in a hybrid working model, based in Krakow.

Highly Desirable:

• Experience with Infor M3.
• Familiarity with manufacturing environments.
• Direct involvement in supporting Infor M3 Cloud or ERP Cloud migration.
• Experience in Life Sciences, pharmaceutical, or biotech sectors.
• Experience in regulated ERP transformation or migration programs.
• Knowledge of GAMP 5 and risk-based validation methodologies.
• Experience supporting audits or inspections effectively.