Compliance IT Quality Assurance Specialist
4 weeks ago
Are you passionate about ensuring the quality and compliance of IT solutions in a regulated environment?
We are seeking a Compliance QA Professional for IT solutions 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 setting the direction for our IT quality system and ensuring compliance with customer and regulatory requirements.
The Position
In this role, you will be responsible for:
- Acting as a QA partner regarding GMP compliance towards the IT department
- Approval of deviations, change requests, qualification, and validation documentation
You will have the opportunity to work on optimizing and streamlining our IT Quality Management System (QMS) to support new and advanced technologies, as well as implementing new digital solutions. Additionally, you may be involved in various projects, including the implementation of new equipment, upgrade of current IT systems, and optimization of business processes using new technologies.
Qualifications
To succeed in this role, you will have:
- An Academic degree within Engineering, Science, Pharmacy, Chemistry, Biotechnology, IT/automation or similar
- Experience within Quality Assurance, Quality Control, Production Support or similar
- Experience with GMP (Good Manufacturing Practice)
- Flair for, and interest in, IT; experience with software validation would be an advantage (GAMP5)
- Professional proficiency in English; knowledge of Danish will be considered an advantage
We are looking for a team player with great interpersonal skills, an innovative mindset, and a passion for quality and compliance. If you are a motivated and detail-oriented individual with a strong background in IT and quality assurance, we encourage you to apply for this exciting opportunity.
About the Department
Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries. Our QA/RA department is a key part of our organization, working diligently to support the entire value chain, from Research & Development to Production and finally Sales & Marketing.
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