Advanced QA Professional

3 days ago


Kalundborg, Denmark Novo Nordisk AS Full time

Do you want to be a part of Quality Assurance (QA) of Biotech & Rare Disease finished products and have broad contact with production? Do you want to be part of an innovative and dynamic environment where your expertise will contribute to the quality and integrity of life-changing pharmaceuticals? If yes, then apply today and join our team. 

The position

As an Advanced QA Professional, you will become part of a competent team that is responsible for setting direction for quality and compliance due to internal and external requirements and releasing batches for the market. As new employee you will be trained to quickly become part of the daily tasks. 

In this role your main responsibilities will be:

Reviewing e.g. batch documentation, SOPs and deviations Taking on the role as Quality Person delegate, releasing batches after ended production QA presence; being physically present on the production lines during production to observe processes and help solve issues in real time Advising stakeholders to keep the right level of quality in the production processes Participating and presenting cases when we are inspected from authorities from around the world Improving processes in own QA area

In this job you will get the opportunity to make an impact for our patients as we release products to the marketed for their benefits. 
We generally offer flexible hours, but overtime can be necessary once in a while due to projects, authority inspections and audits. 

Qualifications

To be successful in this role we expect you to have:

An academic degree within pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and or technology or biology 2+ years of experience within QA or other relevant GMP related job like GMP Coordinator The ability to make decisions based on your GMP knowledge and experience Fluency in written and spoken Danish and English 

On a personal level, you need to have an eye for details, to be dedicated and engaged and able to build strong relations in order to make solid cooperation across the departments. A positive attitude is an absolute necessity as we are the last step before the product reaches our patients, we should be able to deliver with short notice.
We always have space for humour and fun and value relaxed working environment. 


About the department
Biotech & Rare Disease Quality Assurance Finished Products Kalundborg, is a department in a rapid development. We are QA for Biotech & Rare Disease packaging department who is producing haemophilia products and glucagon. It is us who sets the direction for quality of products in development and production to market and we ensure that the production is in compliance with all requirements and regulations at all times.

The department has a very good cooperation both internally and with the rest of Biotech & Rare Disease QA as well as with production and stakeholders. We are engaged in our jobs, have a lot of positive attitudes and an open and honest communication.



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