Compliance IT Specialist

1 month ago


Køge, Køge Kommune, Denmark Novo Nordisk AS Full time
Job Title: Compliance QA Professional for IT Solutions

We are seeking a highly skilled Compliance QA Professional to join our team at Novo Nordisk Pharmatech A/S in Køge. As a key member of our QA/RA department, you will play a crucial role in ensuring the quality and compliance of our IT systems and services.

About the Role

In this exciting position, you will be responsible for setting the direction for our IT quality system and ensuring compliance with regulatory requirements. Your expertise will be instrumental in maintaining the highest standards of quality and compliance in our IT operations.

Key Responsibilities
  • Act as a QA partner for the IT department, providing guidance and support to ensure compliance with GMP regulations.
  • Review and approve deviations, change requests, qualification, and validation documentation to ensure adherence to regulatory requirements.
About the Department

The QA/RA department at Novo Nordisk Pharmatech A/S is a dynamic and collaborative team of 20 employees who work tirelessly to support the entire value chain, from Research & Development to Production and Sales & Marketing. We are committed to delivering high-quality products and services that meet the needs of our customers and regulatory authorities.

Requirements
  • An academic degree in Engineering, Science, Pharmacy, Chemistry, Biotechnology, IT/automation, or a related field.
  • Experience in Quality Assurance, Quality Control, Production Support, or a related field.
  • Experience with GMP regulations and software validation (GAMP5).
  • Professional proficiency in English; knowledge of Danish is an advantage.
About Us

Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries. We are committed to delivering innovative solutions that meet the needs of our customers and regulatory authorities.



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