Descripción del puesto:
You will be part of a team that works to implement, validate and support Windows-based Laboratory IT Solutions. We have a natural desire to always look for smarter ways of doing things and are always working to contribute to improving Novo Nordisk’s standards and services. A key part of the position will be to be involved in a large automation project (+50mdkk investment) building the IT infrastructure for laboratories of the future in Novo Nordisk. The objective is to create fully automated Quality Control (QC) work-cells / lines in R&ED and subsequently scale the to the rest of the company.
Your daily tasks and responsibilities will be to:
- Lead and participate in projects as responsible for the end-to-end direction and quality with respect to IT & Validation
- Work collaboratively across functions with Quality Assurance, IT, Line of Business and vendors to plan, coordinate and execute computer system validation activities
- Perform risk-based validation of GxP systems to ensure requirements coverage and develop validation documents in accordance with corporate processes
- Have the ownership for the development and delivery of complete validation packages, incl. IT Risk Assessment
- Facilitate verification and validation activities including test execution, documentation review and approval
We expect you to have:
- A relevant educational background and experience with GMP. You have experience or interest within pharmaceutical Quality Management, maybe as System Manager, or you have taken part of GxP system validation and wish to grow in your profession. Also experience or interest within Azure DevOps, TIMS3 (HP Quality center), software development and scripted/automated testing is meriting.
- Experience working with the guidelines provided by the global regulatory agencies and authority agencies such as FDA and MHRA in areas such as GxP, USP1058, FDA 21CFR part 11, GAMP Annex11, MHRA ‘GXP’ Data Integrity Guidance and Definitions, PIC/S or corporate interpretations hereof Agile software development
- Good knowledge about GAMP framework
- Solid project management skills
- Excellent communication skills in Danish and English
As a person you are:
- Team-oriented person
- Self-driven, proactive, and responsible
- Willing to bring your thoughts out in the open, creating a healthy discussion, and at the same time, setting a direction
- Able to operate with frequent changes
- Willing to give and receive feedback
About the department
The department QC Technology & IT is part of the Novo Nordisk Research & Early Development (R&ED) family, developing novel analysis for drug candidates in clinical trials all over the world. You will be able to use your skills and talent not only in our department, but across the entire Drug Product Development field.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales.
For further information, please contact Director Mark B. Nielsen at +xx xxxx xxx2 or Maria Melander +xx xxxx xxx3.
7th of August 2022.
Applications will be reviewed continuously, and we will begin conducting interviews already during the posting period, so please do not hesitate to apply.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying 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.
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
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Indrykket: 6 aug 2022
Indrykket: 6 aug 2022
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