Serialization & Traceability Validation Analyst - L3 Expert

Galderma Services Poland sp. z o.o.

Kraków

On-site

PLN 180,000 - 240,000

Full time

2 days ago
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Benefits offered by this job

Private healthcare
Life insurance
Pension plan
Wellbeing benefits
Fitness support
Annual leave
Employee benefits
Learning & development
International environment
Ownership & impact

Job summary

Galderma Services Poland sp. z o.o. is seeking a Business Analyst, Serialization & Traceability L3 Expert in Krakow to lead validation strategy and related documentation in a highly regulated environment.

The role requires hands-on experience with computerized systems validation and cross-functional collaboration across IT Compliance, Quality and business teams. On-site work is four days a week from 2027. The candidate will manage end-to-end validation activities, ensure continued system

Qualifications

  • Strong expertise in GxP and computerized system validation.
  • Experience preparing validation documentation across the full lifecycle.
  • Ability to manage validation independently from start to finish.
  • Experience in regulated pharma or life sciences environments.
  • Excellent documentation and attention to detail.

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, 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
Computerized System Validation
Validation lifecycle
Test planning
Risk assessments
Deviations & CAPA
Serialization/Traceability

Job description

Galderma Services Poland sp. z o.o. is seeking a Business Analyst, Serialization & Traceability L3 Expert in Krakow to lead validation strategy and related documentation in a highly regulated environment.

The role requires hands-on experience with computerized systems validation and cross-functional collaboration across IT Compliance, Quality and business teams. On-site work is four days a week from 2027. The candidate will manage end-to-end validation activities, ensure continued system

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