We are currently seeking a dynamic and experienced Quality Assurance (QA) Specialist with 3-8 years of experience in the medical device or pharmaceutical industry. The adecuado candidate will have expertise in various QA functions, including complaint management, release activities, sterile production, documentation and regulatory compliance. The position is within the External Supplier Organization (ESO) for Sterile Products and You will work closely with ESO suppliers.

Key Responsibilities:

Quality Systems:
Contribute to the development, implementation, and maintenance of robust quality systems, including complaint management, deviation management, change control, CAPA, and risk management processes. Main responsibilities for QMS will be complaint management.

Release Activities:
Execute product release activities in compliance with regulatory requirements and company standards. Ensure timely and accurate release of pharmaceutical products for distribution.

Sterile Production:
Provide QA oversight for sterile manufacturing operations, including aseptic processing,



sterilization processes, and environmental monitoring. Ensure adherence to cGMP guidelines, regulatory standards and applicable ISO standards.

Documentation Management:
Manage and review quality documentation, including batch records, standard operating procedures (SOPs), risk management, validation protocols, and reports. Ensure documentation complies with regulatory requirements, ISO13485, MDR and internal quality standards.

Regulatory Compliance:
Stay abreast of regulatory requirements and industry best practices related to quality assurance. Ensure compliance with FDA regulations, international standards such as applicable ISO standards, and company policies.

Audits and Inspections:
Support internal and external audits and regulatory inspections. Support Due Diligence audits for initial qualification of suppliers. Prepare and review audit documentation, respond to audit findings, and implement cor

📌 Quality Assurance Specialist (Barcelona)
🏢 Galderma
📍 Barcelona