Global QA Specialist - Sterile Devices & Compliance

Galderma; Barcelona; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

Galderma is seeking a dynamic Quality Assurance Specialist with 3–8 years of experience in the medical device or pharmaceutical field. The role focuses on complaint management, release activities, sterile production oversight, and rigorous documentation and regulatory compliance.

You will work within the External Supplier Organization for Sterile Products, collaborating with ESO suppliers to ensure high quality and compliant products globally.

Formación

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
• 5–8 years of experience in quality assurance within medical device, pharmaceutical, or regulated industry.
• Fluency in written and verbal English.
• Strong knowledge of production of sterile products and regulated manufacturing processes.
• Proficiency in documentation management and regulatory requirements (cGMP, FDA, ISO13485, MDR).
• Ability to work independently and collaboratively in a fast-paced environment.

Responsabilidades

• Contribute to quality systems development, complaint management, deviation handling, CAPA, and risk management.
• Execute product release activities in compliance with regulatory requirements.
• Provide QA oversight for sterile manufacturing operations and environmental monitoring.
• Manage and review quality documentation (batch records, SOPs, validation protocols).
• Ensure regulatory compliance with ISO13485, MDR and FDA/regional guidelines.
• Support internal/external audits and supplier due diligence; implement corrective actions.
• Identify opportunities for process improvement and quality enhancement.

Conocimientos

Quality Assurance

Complaint management

Deviation management

CAPA

Risk management

QMS

Release activities

Sterile production

Documentation management

Regulatory compliance

Audits & inspections

Continuous improvement

English fluency

Educación

Bachelor's degree in Pharmacy, Chemistry, Biology, or related field

Descripción del empleo

Galderma is seeking a dynamic Quality Assurance Specialist with 3–8 years of experience in the medical device or pharmaceutical field. The role focuses on complaint management, release activities, sterile production oversight, and rigorous documentation and regulatory compliance.

You will work within the External Supplier Organization for Sterile Products, collaborating with ESO suppliers to ensure high quality and compliant products globally.