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Novo Nordisk

Compliance QA Professional for IT solutions

Fuldtid

Permanent

Københavnsvej 216, 4600 Køge, Danmark

SE PÅ KORT
ID: 2728268
|
Indrykket for 17 dage siden

Are you experienced within pharmaceutical compliance and do you have a passion for IT?

If so, this might be the job for you. We are currently looking for a Compliance Professional who will help us set the direction for Quality Management of digital and IT solutions and services in a regulated environment at Novo Nordisk Pharmatech A/S in Køge.

The position
In the role of a Compliance QA Professional for IT solutions, you will be responsible for setting the direction for our IT quality system and ensuring compliance with the requirements from both customers and authorities around the world.


You will be tasked with:

  • Acting as a QA partner regarding GMP compliance towards the IT department 

  • Approval of deviations, change requests, qualification, and validation documentation


  • In the coming years we will optimise and streamline the IT Quality Management System (QMS) to support new and more advanced technologies, also covering implementation of new digital solutions. Furthermore, Novo Nordisk Pharmatech A/S has various projects in the pipeline, so you may also be involved as IT Compliance responsible in both minor and major projects. These projects cover implementation of new equipment, upgrade of current IT systems and optimization of business processes using new technologies. 


    We offer an exciting and challenging position in an amazing department where focus on collaboration and team spirit are key. There is a significant degree of flexibility, and we value diversity and are always open to discuss new ideas.

    Qualifications
    To succeed in this role, you 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


  • As a person, you have great interpersonal skills and an innovative mind-set. You can work effectively in a team-oriented setting. You are able to communicate with a wide range of stakeholders and enjoy technical conversations and innovative challenges.


    Openness, honesty and focus on continuous improvements and quality mindset are natural parts of your personality and the way you work. Moreover, you have a can-do attitude and focus on opportunities rather than on limitations.


    About the department
    Novo Nordisk Pharmatech A/S is a fully owned subsidiary of Novo Nordisk A/S situated in Køge. 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.


    QA Operations team is a part of the QA/RA department at Novo Nordisk Pharmatech A/S. QA/RA department currently consists of 20 employees working diligently to support the entire value chain, from Research & Development to Production and finally Sales & Marketing. We also cover quality and regulatory affairs related communication with the authorities, our B2B customers, our distributors, and our suppliers.

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