Quality Assurance Expert with Regulatory Acumen

2 weeks ago


Herlev, Herlev Kommune, Denmark Nordic Bioscience Full time
About Nordic Bioscience

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 Description

We 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
Requirements and Qualifications:
  • 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
Estimated Salary: 80,000 - 100,000 USD per annum

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