GxP & System Validation Expert

Posted 12 hours 8 minutes ago by Red - The Global SAP Solutions Provider

Contract
Not Specified
Other
Małopolskie, Kraków, Poland
Job Description

GxP & System Validation Expert

Start: September 2026
Duration: 6-12 months + extensions
Location: Krakow, Poland
Working model: Hybrid
Contract: Freelance/Contract

Role Overview

We are looking for an experienced GxP & System Validation Expert to support ERP Cloud migration activities within a regulated Life Sciences/manufacturing environment.

The role will focus on Computer System Validation (CSV), GxP compliance and validation strategy, ensuring that ERP migration and deployment activities meet the required regulatory and quality standards.

The ideal candidate will bring a combination of ERP Cloud migration, system validation, GxP/CSV and manufacturing experience, ideally with exposure to Infor M3.

Key Responsibilities

  • Define and execute CSV/GxP validation strategies for ERP Cloud migration activities.
  • Ensure ERP migration and implementation activities comply with relevant Life Sciences regulatory requirements and validation standards.
  • Develop and maintain validation documentation throughout the project life cycle.
  • Support system qualification, risk assessments, validation planning and execution.
  • Coordinate and support validation testing activities, including review and approval of test evidence.
  • Ensure appropriate traceability between requirements, risks, testing and validation deliverables.
  • Support audit readiness and ensure documentation is complete and inspection-ready.
  • Work closely with business, Quality, QA, IT and technical teams throughout testing and deployment.
  • Identify validation and compliance risks and support appropriate mitigation activities.
  • Provide guidance on GxP expectations within ERP migration and system implementation activities.
  • Support deployment/go-live activities from a validation and compliance perspective.

Key Skills & Experience

Essential:

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

Highly desirable:

  • Experience with Infor M3.
  • Experience within manufacturing environments.
  • Direct experience supporting Infor M3 Cloud/ERP Cloud migration.
  • Life Sciences/pharmaceutical/biotech experience.
  • Experience with regulated ERP transformation or migration programmes.
  • Knowledge of GAMP 5 and risk-based validation approaches.
  • Experience supporting audits or inspections.