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Lead Auditor

2 months ago

Odense, Odense Kommune, Denmark Orifarm Group Full time
About the Role

We are seeking an experienced Lead Auditor to join our team at Orifarm Group. As a key member of our Quality Management Department, you will be responsible for ensuring compliance with EU GMP EudraLex Volume 4 regulations.

Key Responsibilities
  • Prepare, perform, and follow-up on audits of Pharmaceutical Contract Manufacturers, Laboratories, Packaging Manufacturers, Warehouses, and API Manufacturers.
  • Assess and approve quality and audit documentation from Contract Manufacturers, Laboratories, and API manufacturers.
  • Participate in assessing and following up on supplier oversight to maintain supplier approval status.
  • Contribute to ongoing improvements of processes and procedures in the Pharmaceutical Quality System with the team and cross-functional working groups.
  • Support the QA team in releasing products to the market.
Requirements
  • A master's degree in Pharmacy, Chemical Engineering, Chemist, Biochemist, or a similar field.
  • Experience and knowledge from auditing in the Pharmaceutical industry towards the EU GMP Eudralex Vol. 4.
  • Experience within audit and supplier management processes and in supporting audits/authority inspections.
  • Professional proficiency in Danish and English.
About Orifarm Group

Orifarm Group is a leading parallel importer of pharmaceuticals and a major supplier of pharmaceuticals in Denmark. We are committed to creating access to affordable, high-quality pharmaceuticals and healthcare products. Our core values are responsibility, customer focus, and innovation.

What We Offer
  • A dynamic and inclusive work environment.
  • Opportunities for growth and career advancement.
  • A competitive salary and benefits package.
  • A flexible and remote-friendly work arrangement.