Global QA Specialist, Sterile Products & Compliance

Q-Med Uppsala; Uppsala kommun; On-site; SEK 65,000 - 90,000; Full time

Benefits offered by this job

International setting

European offices

Travel opportunities

Diversity culture

Job summary

Galderma is seeking a QA Specialist to join our External Supplier Organization for Sterile Products. The role focuses on quality systems, regulatory compliance, and continual process improvement in a global setting.

You will work with external suppliers worldwide, oversee sterile production, release activities, documentation, and risk management, ensuring cGMP, ISO 13485 and MDR standards are met.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, or Biology.
• 2–5 years QA experience in regulated industry.
• Fluency in written and spoken English; additional languages are an advantage.
• Strong knowledge of quality systems and regulatory requirements.

Responsibilities

• Quality Systems – develop, implement, and maintain quality systems including complaint, deviation, change control, CAPA, and risk management; focus on complaint management.
• Release Activities – perform product release in compliance with regulatory requirements.
• Sterile Production – QA oversight for aseptic processing, sterilization, and environmental monitoring.
• Documentation Management – review batch records, SOPs, risk assessments, validation protocols, and reports.
• Regulatory Compliance – stay up to date with FDA, ISO 13485, MDR, MDR and other regulations.
• Continuous Improvement – identify opportunities for process and quality improvements.

Skills

Quality Assurance

Regulatory compliance

Documentation

English language

Education

Bachelor’s degree in Pharmacy, Chemistry, or Biology

Job description

Galderma is seeking a QA Specialist to join our External Supplier Organization for Sterile Products. The role focuses on quality systems, regulatory compliance, and continual process improvement in a global setting.

You will work with external suppliers worldwide, oversee sterile production, release activities, documentation, and risk management, ensuring cGMP, ISO 13485 and MDR standards are met.