Compliance QA Professional for IT solutions (Denmark, Køge)

Jobbeskrivelse
Placering
Køge, Denmark

Jobkategori
Quality

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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.

Working at Novo Nordisk Pharmatech
Novo Nordisk Pharmatech A/S has approximately 500 employees and is 100% owned by Novo Nordisk A/S. The ability of Novo Nordisk Pharmatech A/S to produce and deliver quality products to the pharmaceutical industry, combined with our complete range of services within the regulatory requirements, makes us a preferred supplier to many global pharmaceutical companies. Novo Nordisk Pharmatech A/S is a growing company, which will provide many exciting projects in the future and good development opportunities in the job.

Contact
For further information, please reach out to QA Manager, Daniel Grundahl, on +45 31 97 00 09.

Deadline
20 October 2024.

Please upload your CV in English. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.