Regulatory Compliance Specialist

7 days ago

Køge, Køge Kommune, Denmark Novo Nordisk Full time

The Position

As a key member of our procurement team, you will be responsible for 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.

We are looking for a highly skilled and detail-oriented individual who is passionate about maintaining high standards of supplier compliance and documentation accuracy. If you have a strong understanding of GMP standards and documentation requirements, excellent communication skills, and experience in procurement, supply chain management, or quality management, we encourage you to apply.

About the Department

The Inbound Supply team consists of 10 dedicated colleagues that cover different areas of responsibilities like sourcing, material and supplier implementation, GMP documentation, and category management.

Working at Novo Nordisk Pharmatech

Novo Nordisk Pharmatech A/S is a fully owned subsidiary of Novo Nordisk A/S situated in Køge. We are a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries, supplying products such as recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds as well as raw materials for Novo Nordisk A/S.

We offer a dynamic and collaborative work environment, exciting projects, and good development opportunities. If you are enthusiastic and meticulous with a passion for maintaining high standards, we encourage you to apply for this challenging role.

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