- Validation with the concept of Science and Risk-based Validation.
- Preparation of validation documents and plans for both low and high complexity projects.
- Contribute to maintaining compliance across building DF.
- Support training and in-house help for SRV.
- OPV/SE - Assist supporters in maintaining the validated state continuously.
- Relevant academic education – ideally a natural science education such as engineering, pharmacist, chemist or similar.
- It is a plus if you have experience from the pharmaceutical industry, but it is certainly not a prerequisite.
- Experience with validation in projects and preferably experience with validation/qualification in a GMP environment.
- Desire to support a production that is sometimes characterized by a changeable everyday life.
- Good overview and a sharp analytical sense, which makes it easy for you to cut to the bone and see through connections between processes, materials and equipment.
- Professional competence in English.
Advanced Assembly and Pack Professional - Kalundborg, Danmark - Novo Nordisk A/S
Beskrivelse
Do you want to be part of the packaging and assembly factory of the future? Are you driven to use your knowledge and experience to help others succeed? Are you ready for an everyday life where the focus is on quality and the daily delivery of vital medicine to our patients?
Now is the time that you have the opportunity to be involved and make your active mark on the everyday life of a whole range of colleagues in the Finished Production (FP) department at IFP Kalundborg.
The Position
We are looking for an Assembly and Pack Professional Technical Supporter with experience within a GMP regulated working environment.
The main tasks will be to:
You will be part of the Oral Pack Technical Support, which consists of 25 highly committed and skilled employees. We are known for our high professional level and stable delivery ability.
Qualifications
To succeed in this role, you have:
Although you may not be able to nod in recognition to all the points, we would still very much like to hear from you and read your application - you may be just the person we are looking for
It is an advantage if you have worked in finished product production before, but not a requirement. It is important that you thrive in a challenging, dynamic and changeable environment, and that no task is too big or small for you to solve. We would love to hear from you if you are proactive, constructive, solution-oriented with a flexible mindset.
As a person, you are aware of your responsibility and manage to make the necessary decisions to solve challenges with a sense of efficiency and quality. You will have many different stakeholders at the same time, and therefore we hope that you like to interact with other people, have a great passion and motivation for the work you do, and are ready to run at the front with the baton.
About the department
You will be part of Novo Nordisk finished product production, which has around 7.000 employees across seven production sites and five countries. We are the last, but very important, link in the value chain before the finished products can be sent to patients all over the world. In the finished goods production in Kalundborg, we have 350 employees who are responsible for assembling and packaging diabetes products on our fully automatic production lines.