Experienced Quality Control Specialist

4 weeks ago

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

We are seeking an experienced Quality Control Professional to join our team at Novo Nordisk Pharmatech in Køge. As a key member of our QC department, you will be responsible for ensuring the quality and compliance of our products, working closely with our chemists and technicians to maintain industry standards, GMP, and regulatory requirements.

Key Responsibilities
  • Product responsible: Ensure understanding of the relationship between product and the QC analyses
  • Continuously improve and optimize our processes
  • Qualify, validate, and implement respective analytical equipment and analysis methods
  • Participate in projects and collaborate with stakeholders across the organization
  • Approve analytical results and secure their timely delivery
  • Participate in and facilitate systematic problem solving (SPS)
  • Assist in the preparation of documentation for customers and authorities
  • Present documentation during inspections and audits
Requirements
  • A scientific academic degree such as cand. pharm., cand. scient., chemical engineer or similar; a Ph.D. in a relevant area could be an advantage
  • Strong chemical background in organic chemistry or another related field
  • Some years of experience as an analytical chemist with techniques such as HPLC, GC, titration, and Spectrophotometer, preferably within GMP and the pharmaceutical industry. Experience with analysis of enzymes is an advantage
  • Understanding of ICH guidelines and pharmacopeia
  • Relevant LEAN experience from a comparable position or education, combined with a natural eye for upscaling work processes and reduce waste
  • Strong communication skills and professionally proficient in both written and spoken Danish and English
About the Department

We are a well-functioning department, and you will be joining a team of 10 highly professional and motivated chemists, lab technicians, and an Analytical Coordinator who support the development of products and production with high-quality assays. The team also handles tasks like stability tests, raw material controls, input to regulatory documentation, implementation of new analytical equipment and software, CMO collaboration, development, and validation of methods, etc.

The laboratory is moving towards more digitalisation and use of data analyses, and we are in the process of replacing our current Laboratory Information Management System (LIMS) solution.

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