Business Analyst, Serialization & Traceability L3 Expert

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SeniorOn-site·KrakówFull-time

#447936·Dodano 24 dni temu·5

Źródło: nofluffjobs.com

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Tech Stack / Keywords

GXPComputerized System Validation

Firma i stanowisko

Galderma is a global leader in dermatology with a presence in approximately 90 countries. The company focuses on delivering a science-based portfolio of premium dermatology products in Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Founded in 1981, Galderma emphasizes partnerships with healthcare professionals and advancing dermatology globally.

Wymagania

Strong expertise in GxP and Computerized System Validation.
Hands-on experience preparing and managing validation documentation.
Experience managing the full validation lifecycle for computerized systems.
Strong understanding of testing, risk assessments, deviations, and validation controls.
Experience within pharmaceutical, life sciences, or another highly regulated environment.
Strong attention to detail and a structured approach to documentation.
Able to manage validation activities independently from start to finish.
Strong communication and collaboration skills across technical and business teams.
Experience with serialization or traceability systems is beneficial.

Obowiązki

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 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.

Benefity

Private healthcare and life insurance.
Pension plan.
Health and wellbeing benefits including access to fitness support.
Annual leave and additional employee benefits.
Learning and development opportunities.
International, collaborative environment with ownership and impact opportunities.
Sport subscription.
Flat structure.
Hybrid Work Allowance.
STI Bonus.
Corrective glasses reimbursement.
Free coffee.
Mobile phone.
In-house trainings.
Modern office atmosphere.

Opieka zdrowotna

Concierge

Karta sportowa

Szkolenia wewnętrzne

Premie

Telefon

Galderma

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