GMP Compliance Specialist

4 weeks ago

Køge, Køge Kommune, Denmark Novo Nordisk Full time

About the Role

We are seeking a highly skilled GMP Compliance Specialist to join our Inbound Supply team. 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.

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 the Company

Novo Nordisk Pharmatech A/S is 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.

Working at Novo Nordisk Pharmatech

Novo Nordisk Pharmatech A/S has approximately employees and is % owned by Novo Nordisk A/S. The ability of Novo Nordisk Pharmatech A/S to produce and deliver quality products to the pharmaceutical industry, combined with our complete range of services within the regulatory requirements, makes us a preferred supplier to many global pharmaceutical companies.

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