Regulatory and Quality Specialist
On-siteLangeskov, South Denmark, Denmark
Job Summary
Ensure quality and compliance across operations by managing GDP, HACCP, and food safety regulations for products and distribution. Administer the D4 quality management system, handling document control, workflows, and user training. Conduct internal audits, track deviations, and lead CAPA processes while supporting external and supplier audits. Collaborate with Supply Chain, Procurement, and Product teams to translate regulatory requirements into practical processes. Perform risk assessments and root cause analyses to continuously improve procedures. Work closely with the Regulatory team on selected projects and deliver relevant quality training to colleagues.
Required Qualifications
- minimum 3 years experience from a Quality, QA, Compliance and/or Regulatory role
- experience from animal health, pharma, medico or feed industry
- experience with quality management systems
- experience as administrator or superuser of an electronic QMS such as D4 or equivalent
- practical experience with document control, deviations, CAPA and audits
- practical understanding of GDP, HACCP, ISO 9001
- interest in regulatory requirements and the ability to translate requirements and regulations into practical and applicable processes
- ability to work structured and thrive with many parallel tasks and shifting priorities
- ability to take responsibility, work independently and follow tasks through to completion
- ability to work closely with daily operations and collaborate with many different professional groups
- ability to communicate professionally in both Danish and English – written and orally
Desired Qualifications
- experience from animal health, pharma, medico or feed industry
- experience as administrator or superuser of an electronic QMS such as D4 or equivalent
- practical experience with document control, deviations, CAPA and audits
- practical understanding of GDP, HACCP, ISO 9001 and ISO 13485
- experience with one or more of the areas feed, GDP/distribution, animal by-products, medical devices or other regulated product areas
- experience with one or more of the areas feed, GDP/distribution, animal by-products, medical devices or other regulated product areas
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