GxP Validation Lead & Test Manager

Galderma

Kraków

Hybrid

PLN 240,000 - 300,000

Full time

2 days ago
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Job summary

Galderma is seeking a Test Manager & Validation Lead in Kraków, Poland to own validation activities across the serialization and broader IT landscape. You will ensure GxP systems are validated and stay validated, covering strategy, documentation, testing, and close collaboration with IT, Quality, Compliance and business teams.

The ideal candidate brings strong GxP expertise, hands-on validation documentation experience, and the ability to manage the full lifecycle independently, with a focus on

Qualifications

  • Strong expertise in GxP validation of computerized systems (CSV) and regulatory expectations.
  • Hands-on experience preparing and managing validation documentation including plans, risk assessments, specs, and reports.
  • Experience managing the full validation lifecycle for computerized systems in highly regulated environments.
  • Solid understanding of testing, deviations, validation controls, and traceability.
  • Experience in pharmaceutical/life sciences or similar regulated domains.

Responsibilities

  • Define and manage end-to-end validation strategies and plans.
  • Prepare and maintain validation documentation, including risk assessments, validation plans, functional and technical specifications, test protocols, test execution reports and final validation reports.
  • Coordinate and participate in test execution and review.
  • Manage deviations, non-conformities and follow-up actions.
  • Ensure systems remain in a validated state following changes and updates.
  • Work closely with IT Compliance, Quality, and business teams.
  • Provide validation expertise throughout implementation and ongoing operations.

Skills

GxP validation
validation lifecycle
documentation
risk assessments
test protocols
communication skills

Job description

Galderma is seeking a Test Manager & Validation Lead in Kraków, Poland to own validation activities across the serialization and broader IT landscape. You will ensure GxP systems are validated and stay validated, covering strategy, documentation, testing, and close collaboration with IT, Quality, Compliance and business teams.

The ideal candidate brings strong GxP expertise, hands-on validation documentation experience, and the ability to manage the full lifecycle independently, with a focus on

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