QA Specialist for Quality Assurance

8 hours ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk AS Full time

About Us:

Novo Nordisk A/S is a dynamic company in the pharmaceutical industry, striving for excellence without fixating on perfection. We drive innovation and seize opportunities to develop.

Job Title: QA Specialist

We are seeking an experienced Quality Assurance (QA) specialist to join our team. As a QA specialist, you will play a crucial role in ensuring the quality of our products and services.

Key Responsibilities:

  • To act as a Quality Assurance representative for QC servicing our QC and CMO laboratories, ensuring compliance with internal and external requirements.
  • To contribute to finding solutions for ad hoc questions and challenges within compliance of QC laboratories.
  • To approve documentation needed for the operation of the laboratories, such as change requests, deviations, and SOPs.
  • To assist colleagues in assuring qualification of laboratory equipment and validation of methods for analysis of drug product for the market.
  • To work proactively with QA oversight to identify areas where compliance can be strengthened.
  • To implement a risk-based approach to the quality control process and product, balancing patient safety, compliance, and effective business conduct.
  • To drive local and/or cross-functional initiatives to support ET Quality and stakeholders' strategic initiatives.

Requirements:

  • An academic degree as pharmacist, engineer, or similar.
  • At least 6 years of experience from a pharmaceutical or medical device organization, with a solid and up-to-date knowledge of quality and GMP requirements.
  • Excellent stakeholder management skills, even in addressing complex matters and tough decisions.
  • Fluency in both spoken and written English.
  • Proficiency in Danish is an advantage.


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