Senior QA Professional for CMC API Facilities
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Bagsværd
- Quality
- Bagsværd
Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, this position as Senior QA Professional can be a unique possibility for you.
As part of Novo Nordisk’s R&D family, CMC Development makes a difference for patients with chronic diseases across the world and the organisation develop, manufacture and distribute drug candidates for non-clinical and clinical trials.
CMC Development and CMC QA is an ambitious organisation with a strong culture, always seeking to solve problems, have an eye for the entire business and do our best to deliver despite any obstacles along the way. We have a high focus on delivering high quality to our customers which is why we are looking for a Senior QA Professional to take an active part in securing our quality level.
About the department
CMC API QA has a mission to assure that each and every Active Pharmaceutical Ingredient (API) activity in our development projects live up to the cGMP requirements for the safety of our patients. We are 25 ambitious colleagues divided into two teams. You will be part of a dedicated team of 10 highly qualified technicians and professionals ensuring the qualification of facilities, equipment and status assignment of products in Upstream Facilities in CMC API.
The position
In this role, you will be responsible for delivering best-in-class quality of qualification of facilities and equipment used for GMP production of the API for clinical studies. This includes you to collaborate cross functional with scientists in the pilot upstream production and your QA colleagues.
In your daily work you will challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents from Contract Manufacturing Organisation (CMO). You will evaluate requirements and set the quality direction for the pilot upstream production and projects. Most situations, we expect you to handle independently and with routine, and often apply subject matter knowledge to the tasks you are handling. Moreover, you have the ability to identify better practice and create improvements to QA processes.
In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development. We make a difference in the lives of people participating in clinical trials in Novo Nordisk A/S, by ensuring that the products they receive are safe, of the highest quality and produced in compliance with legislation.
Qualifications
You hold an MSc in Pharmacy, Engineering, Biology, Chemistry or similar. It is expected that you have at least 5 years of experience within a GMP and LEAN focused environment combined with understanding of how the pharmaceutical industry works. The most important asset you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level.
If you are a lead auditor, we will support you to have a minor part of the role, to be part of an auditor team where you are responsible for conducting successful audits at CMO´s working for Novo Nordisk.
You are a person interested in building sound relations with your broad stakeholder network and you enjoy going out meeting your stakeholders and proactive bringing QA in action within the organisation.
Furthermore, you are a self-driven and independent person with a high sense of responsibility and initiative. You thrive in a dynamic environment where teamwork is on top of the agenda, and like working with many different stakeholders.
As we operate both in a national and an international environment, you must speak and write Danish and English fluently.
Working at Novo Nordisk
At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent.
Contact
For further information, please contact Charlotte Hellesøe Ørtoft +45 3075 1742.
Deadline
05 April 2020. Applications will be reviewed ongoing.
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 "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 24.3.2020, 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.
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