GMP Compliance Specialist

4 weeks ago


Køge, Køge Kommune, Denmark Novo Nordisk Full time
About the Role

We are seeking a highly skilled and detail-oriented GMP Supporter to join our Inbound Supply team. As a key member of our procurement team, you will play a vital role in ensuring that GMP documentation requirements for suppliers are meticulously managed and in compliance with industry standards.

Key Responsibilities
  • Handle GMP documentation related to suppliers and materials in Inbound Supply, serving as qualification responsible and writer for both packaging and raw materials.
  • Improve Inbound Supply processes to meet quality and performance goals, and develop strategies to enhance overall supplier compliance.
  • Support Inbound Supply with GMP-related tasks, manage change notifications related to Inbound Supply materials, and foster a quality mindset within the team.
  • Assist in the evaluation and selection of suppliers, focusing on their adherence to GMP documentation requirements, and participate in contract negotiations and documentation of new suppliers and materials.
  • Monitor and maintain a robust documentation system to track supplier GMP compliance, ensuring accuracy and completeness of records, and handle Deviation (DV) and Change Request (CR) cases related to Inbound Supply.
Requirements
  • Preferably a bachelor's degree in Life Sciences, or a related field. Non-academic education will also be considered for candidates with long experience.
  • Some years of experience in procurement, supply chain management or quality management with a focus on GMP documentation within a regulated industry.
  • Strong understanding of GMP standards and documentation requirements, with the ability to ensure supplier compliance and maintain accurate records.
  • Excellent communication skills in English, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
About Us

Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries. We are a growing company with a complete range of services within the regulatory requirements, making us a preferred supplier to many global pharmaceutical companies.



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