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)
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