Senior Serialization & Validation Analyst (GxP Expert)

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

Benefits offered by this job

Private healthcare

Life insurance

Pension plan

Health & wellbeing benefits

Annual leave

Learning & development opportunities

International, collaborative work环境

Job summary

Galderma, a global dermatology leader, seeks a Business Analyst, Serialization & Traceability L3 Expert based in Krakow. You will own validation activities across serialization and IT landscapes, ensuring GxP systems stay validated throughout their lifecycle and partnering with IT, Quality, Compliance and business teams.

Ideal candidates bring deep CSV experience, strong attention to detail, and the ability to manage validation from start to finish in a highly regulated environment.

Qualifications

• Strong 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 life sciences regulatory environment.

Responsibilities

• Define end-to-end validation strategies and plans.
• Prepare and maintain validation documentation and reports.
• Coordinate and participate in test execution and reviews.
• Manage deviations and follow-up actions.
• Ensure systems stay validated after changes.
• Collaborate with IT, Quality and business teams.
• Support test scenarios and data availability.
• Provide validation expertise during implementation and operations.

Skills

GxP expertise

CSV (validation)

Validation documentation

Full lifecycle validation

Pharma/regulatory experience

Attention to detail

Independent management

Communication skills

Serialization/traceability exposure

Job description

Galderma, a global dermatology leader, seeks a Business Analyst, Serialization & Traceability L3 Expert based in Krakow. You will own validation activities across serialization and IT landscapes, ensuring GxP systems stay validated throughout their lifecycle and partnering with IT, Quality, Compliance and business teams.

Ideal candidates bring deep CSV experience, strong attention to detail, and the ability to manage validation from start to finish in a highly regulated environment.