Experteer Overview

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In this role, you will uphold robust quality systems for sterile pharmaceutical products within Galderma’s External Supplier Organization. You’ll drive complaint handling, release activities, and documentation governance, ensuring compliance with cGMP, ISO13485, MDR, and FDA standards. You’ll oversee sterile production and supplier audits, enabling timely product releases and continuous quality improvement.

This position sits at the heart of a integral capability center, offering cross-functional collaboration and impact across regions.

Compensaciones / Beneficios

- Develop and maintain quality systems (complaint, deviation, change control, CAPA, risk management)
- Lead product release activities in line with regulatory and company standards
- Provide QA oversight for sterile manufacturing (aseptic processing, sterilization, environmental monitoring)
- Manage quality documentation (batch records, SOPs, risk management, validation protocols)




- Ensure regulatory compliance (FDA, ISO13485, MDR, other guidelines)
- Support internal and external audits and inspections, including supplier due diligence
- Identify and implement process improvements to optimize quality and efficiency

Responsabilidades

- Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field
- 5-8 years of QA experience in medical device, pharmaceutical, or regulated industry
- Fluency in English; additional languages assets xugodme
- Strong knowledge of cGMP, FDA regulations, ISO13485, MDR and relevant standards
- Proficiency in documentation management and regulatory compliance
- Excellent communication; ability to work independently and collaboratively in a fast-paced environment

Requisitos principales

- diversity u0026 inclusion
- professional development
- international environment
- global career opportunities
- exposure to cross-functional projects
- travel opportunities

📌 Quality Assurance Specialist (Barcelona)
🏢 Galderma
📍 Barcelona