Quality Assurance Expert with Regulatory Acumen
2 weeks ago
Nordic Bioscience is a research-driven company specializing in biomarker development for diagnostics and prognosis of chronic diseases. Our laboratory conducts analyses of clinical samples for external partners, including CROs and Pharma/Biotech companies.
Job DescriptionWe are seeking an experienced Quality Assurance Professional to join our small QA team. As a key member of the team, you will provide expert support on industry standards and regulations, collaborate with cross-functional project groups, and contribute to maintaining our commitment to excellence and dedication to clients.
Responsibilities:- Support QA team and project groups on GxP and regulatory requirements, driving quality assurance through collaboration
- Collaborate with the QA manager and colleagues during client and authority inspections, rotating through various roles, including QA subject matter expert and audit host
- Lead investigations into quality-related issues, perform root cause analysis, and implement corrective and preventive actions
- Identify opportunities for process improvement, conducting internal audits, and enhancing quality assurance practices
- Strong understanding of GxP and industry standards, with a deep desire to advance and become a leading QA specialist
- Experience from QA roles within the pharmaceutical or biotech industry
- Excellent communication skills, expressing ideas effectively in English
- Ability to thrive in a dynamic environment, adapting to changing tasks and project teams
- Innovative mindset with a solutions-oriented approach
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