GxP Validation Lead – Serialization & Traceability Expert

Galderma; Kraków; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Private healthcare and life insurance

Pension plan

Health and wellbeing benefits

Annual leave and additional employee  

Learning and development opportunities

International, collaborative work环境

Job summary

Galderma in Krakow, Poland, is seeking an experienced Test Manager & Validation Lead to own validation activities across our serialization and IT landscape. This hands-on role covers validation strategy, documentation, testing and collaboration with IT, Quality, Compliance and business teams.

You'll define end-to-end validation plans, maintain validation docs, coordinate test execution, manage deviations, and ensure systems stay validated after changes.

Qualifications

• Expertise in GxP and Computerized System Validation.
• Experience preparing and managing validation documentation.
• Experience managing full validation lifecycle for computerized systems.
• Strong testing, risk assessments, deviations and validation controls.
• Experience in pharmaceutical or regulated life sciences environment.
• Attention to detail and structured documentation.
• Ability to manage validation activities end-to-end.
• Strong communication across technical and business teams.
• Serialization or traceability knowledge is a plus.

Responsibilities

• Define and manage end-to-end validation strategies and plans.
• Prepare and maintain validation documentation including risk assessments, validation plans, functional and technical specification, test protocols, test execution reports and final validation reports.
• Coordinate and participate in test execution and reviews.
• Manage deviations, non-conformities and follow-up actions.
• Ensure systems remain in a validated state following changes.
• Work with IT Compliance, Quality, and business teams and technical colleagues.
• Support functional test scenarios and ensure appropriate test data is available.
• Provide validation expertise throughout implementation and operational activities.

Skills

GxP & CSV Validation

Validation strategy & planning

Documentation & audits

Test execution & reviews

Pharma / Life sciences

Regulatory compliance

Validation lifecycle management

Cross-functional communication

Serialization/Traceability knowledge

Job description

Galderma in Krakow, Poland, is seeking an experienced Test Manager & Validation Lead to own validation activities across our serialization and IT landscape. This hands-on role covers validation strategy, documentation, testing and collaboration with IT, Quality, Compliance and business teams.

You'll define end-to-end validation plans, maintain validation docs, coordinate test execution, manage deviations, and ensure systems stay validated after changes.