Analysis QA Professional in Research & Development
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Måløv
- Quality
- Måløv
Are you ready to ensure compliance and high quality in development laboratories and analytical activities in development projects? Then we may have just the right job for you in CMC OPF & Analysis QA.
About the department
Novo Nordisk is changing going into new therapeutic areas and digital improvements. Thus, we are seeking a new colleague to help us support this transition in CMC Development. Located in Måløv, in CMC OPF & Analysis QA you will be working with 6 highly dedicated colleagues ensuring that the laboratories and their analysis activities for all Novo Nordisk development projects live up to cGMP requirements.
The job
In close cooperation with your colleagues, you act as QA for our analytical development departments. Your main responsibility will be to quality assure the laboratories and thereby contribute to, that the products always are of high quality and analysed in full compliance with the current rules and guidelines. You will approve method qualification and validation documentation from CMC analytical departments and contract manufactures (CMOs) in the process of release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials. Thus, you will work and be consulted in various development projects on analytical topics and be expected to have a risk based approach to the development process and product. In connection to this you find the right balance between patient safety, compliance to requirements and effective business conduct. In addition, the job also includes approval of qualification and validation documentation for laboratory equipment and IT systems.
CMC Development’s continuing high level of audit and inspection readiness is on top on your agenda. Therefore, in CMC Analysis QA we work with QA oversight where you proactively will identify areas where our stakeholders’ compliance can be strengthened and how we can work smart with digital solutions and automated processes. Thus, you will work in close collaboration with main stakeholder departments to identify opportunities for optimization and simplification.
Qualifications
You hold an academic degree as pharmacist, engineer or similar and have at least 3 years of experience from a pharmaceutical organisation, preferable within quality assurance or quality control, where you have gained a solid and up-to-date knowledge of quality and GMP requirements. The ideal candidate has solid knowledge within validation of analytical methods, equipment qualification and is familiar with laboratory computer system and IT validation.
On a personal level, you contribute positively to our team and enjoy working with people from different professional backgrounds who are dedicated towards meeting our common goals. You are eager to see things moving forward in a dynamic environment where projects and processes vary, which demands the need for your flexibility and skills to organise and drive tasks. Thus, making an impact with your ideas and suggestions.
You take a pragmatic approach to problem solving and have a strong quality mind set. Good communication skills are a must as you are to communicate complex content to people with different backgrounds and skills. You are therefore expected to be fluent in Danish and English
We look for an open-minded person with an outgoing attitude and natural networking skills. Additionally we would enjoy having a straightforward person with a good sense of humour in our department.
Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information please contact Nikolaj Nielsen +45 30754662
Deadline
24 April 2020
We look at candidates and perform interviews continuously.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 6.4.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Måløv
- Fredag den 24. april 2020
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