QA Specialist - Oral Solid Dosage Forms
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Måløv
- Quality
- Måløv
Are you ready to take up new complex quality challenges? Do you want to be part of the team bringing Rybelsus® to patients all over the world? Novo Nordisk has built a new factory in Måløv which will be part of setting new standards for diabetes treatment. To succeed with this ambition, we need people with high level of team spirit, having high engagement and who thrives in a constant changing environment.
About the department
In 2004 an ambitious and path-breaking journey began for us to become the first medical company delivering GLP-1-based tablets to the market. In 2020 we delivered Rybelsus® tablets to the first patients and going forward millions of patients with type-2 diabetes will have an oral alternative to injectable preparation. This is a result of competent, innovative and engaged employees’ efforts across the organization, who are proud to use their dedication to make totally new standards within the diabetes treatment. Join us at our journey – a possibility to make a personal and professional development.
Oral Finished Products QA is a department which employ approximately 30 skilled and motivated colleagues. We work with assuring quality and compliance of late stage development as well as production processes, facilities, equipment, QC lab, stability studies and the quality management system. Last but not least, - the release of tablets for the market.
In OFP QA we make a huge effort for you as a new employee to be off to a good start. During the first few days you will spend some time with other new employees in the OFP area, where you will get an exciting introduction to OFP. The manager will welcome you, and a colleague will act as a mentor and go through your individual training plan. We know how important it is, and we are looking forward to meeting you.
The job
Overall you will play a key role in setting direction for Quality in the Oral Finished Product area in close cooperation with your peers in production and manufacturing development. Your main focus will be assuring the manufacture of drug product and finished product for the market is compliant with internal and external requirements.
You will serve as a daily sparring partner for your colleagues and you will advise and help them solving complex professional matters related to manufacture of oral solid dosage forms. You will be using your profound knowledge and understanding of regulatory requirements for tablet development and production and it will be expected that you act as a role model when giving support and advice on direction and process expertise on relevant compliance activities.
You are able to act in an environment characterised by tight deadlines and high workload and you contribute to find the right balance between patient safety, compliance to requirements and effective business conduct.
Corporation with quality specialists across Novo Nordisk will be a major task to ensure right interpretation of latest internal and external quality standards – including your OFP QA qualification and cleaning specialist colleague. Identify and drive large projects will also be part of your job.
Qualifications
You have a master’s degree in pharmacy, engineering or a related field and at least 8-10 years of experience from the pharmaceutical industry of which you have gained 4-5 years of solid experience within cGMP standards for development and market production of oral solid dosage drug products. Furthermore, you have experience with batch release and process formulation.
You are ready to take on responsibility, and you convey your knowledge and experience with a steady hand. We expect you to build trustful relations across the organisation and to competently enjoy being the expert your colleagues can count on for advice and sparring. You use your excellent cooperation skills when you manage your stakeholders both in- and externally to ensure reaching solutions that will meet both requirements and stakeholder interests.
As a person, you have a high drive paired with strong interpersonal skills and have a passion for creating visible results in a complex organisational context. You are proactive and able to plan ahead ensuring a high level of quality in your work even in busy periods. As we work in a global business environment, we expect you to be proficient in English, in speech as well as in writing.
Working at Novo Nordisk
At Novo Nordisk, you will join a patient-centred culture of talented professionals. We respect individuality and empower you to make the most of your potential. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
Contact
For further information, please contact Sine Godiksen at +45 3075 1426.
Deadline
14 August 2020.
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 "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 9.7.2020, 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.
- Produktspecialist
- Måløv
- Fredag den 14. august 2020
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