Quality Assurance Specialist

We are seeking an experienced Quality Assurance Specialist for a 12-month contract. This role will support ongoing GxP compliance efforts across manufacturing, quality systems, and regulatory operations. The ideal candidate will bring a broad background in pharmaceutical QA.

Key Responsibilities:

• Ensure compliance with GxP regulations across operations.
• Support batch record review, product release, and deviation/investigation management.
• Participate in internal and external audits, including preparation, execution and follow-up.
• Review and approve SOPs, change controls, CAPAs, and other quality documentation.
• Support regulatory inspections and contribute to inspection readiness activities.
• Assist in training programs and continuous improvement initiatives within QA.
• Lead or support quality risk assessments and contribute to the development of risk mitigation strategies across operations.

Qualifications & Experience:

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, or related field.
• Minimum 3-5 years of QA experience in the pharmaceutical or biotech industry.
• Strong knowledge of EU GMP and ICH guidelines with experience in sterile manufacturing
• Experience with quality systems, Veeva in particular would be advantageous.
• Fluent in English; proficiency in a Scandinavian language is a plus.

Contract:

• Start date: 1st July
• 12 month contract
• 40 hours per week
• Hybrid (must be based in Denmark/Sweden/Norway)