Senior QA Professional for CMC API QA
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Bagsværd
Would you like to work with various tasks and have an impact? Do you value good team spirit where everyone is each other's sparring partners and respect each other's opinions and knowledge? Do you also have a strong quality mind-set and great interpersonal skills? Do you want to play an important role in ensuring the quality and safety of products for clinical trials??
If this sounds like you, then this might be the right job for you.
The position
As a senior QA Professional in CMC API QA, Team Facility & Equipment you are responsible for delivering best-in-class quality of qualification of facilities and equipment used for GMP production of the API for clinical studies. Apart from daily tasks, you will also be part of processgroup work, projects and optimising as we support pilotprojects from cell bank to phase 3. You can collaborate cross functional with scientists in the API Pilot production and your Quality Assurance colleagues. Furthermore,
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.
About the department
In department CMC API QA, we are 24 skilled and motivated employees, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for clinical trials. We participate as QA for smaller or bigger investment projects to make our Pilot facilities more prepared for the future. We have the responsibility of releasing API from contract manufacturers across the globe. We are divided into two teams, Facility & Equipment and Product & Materials. You will be part of the Facility & Equipment team consisting of 9 Quality Assurance professionals. The Team is responsible for assignments at the API pilot facilities assuring the quality of the facility and the Equipment.
In the department, we value teamwork, diversity, and humour very high, and we will make sure that you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor.
Contact
For further information, please contact Associate Manager Charlotte Hellesøe Ørtoft +45 3075 1742 or Sr. QA professional Tine Harboe Wolf +45 3079 3795
Deadline
7th of January 2023. Applications will be reviewed ongoing. Interviews are held continuously, and employment can thus potentially take place before the deadline.
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.
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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If this sounds like you, then this might be the right job for you.
The position
As a senior QA Professional in CMC API QA, Team Facility & Equipment you are responsible for delivering best-in-class quality of qualification of facilities and equipment used for GMP production of the API for clinical studies. Apart from daily tasks, you will also be part of processgroup work, projects and optimising as we support pilotprojects from cell bank to phase 3. You can collaborate cross functional with scientists in the API Pilot production and your Quality Assurance colleagues. Furthermore,
- You identify and contribute to strengthening our production facilities compliance level and act as a consultant for them.
- You contribute to find solutions for ad hoc questions and challenges within cGMP compliance.
- You challenge and approve documentation regarding qualification of facilities and equipment as well as other supporting documents for the Pilot facilities.
- You evaluate requirements and set the quality direction for the API Pilot production and projects.
- In most situations, you are expected to handle independently and with routine, and often apply subject matter knowledge to the tasks you are handling.
- You can 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 GMP and Quality Assurance.
- You understand how the pharmaceutical industry works.
- You can work with many tasks at the same time and can make decisions and follow up on quality related problems.
- You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity.
- The most important asset that you can have to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level.
- 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 the top of the agenda, and like working with many different stakeholders.
- It is key that you value being part of a top-performing team, were we use regular feedback and challenge each other to become even better.
- You have a good sense of humour and appreciate a good laugh every now and then.
- You must speak and write Danish and English fluently as we operate both in a national and an international environment.
About the department
In department CMC API QA, we are 24 skilled and motivated employees, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for clinical trials. We participate as QA for smaller or bigger investment projects to make our Pilot facilities more prepared for the future. We have the responsibility of releasing API from contract manufacturers across the globe. We are divided into two teams, Facility & Equipment and Product & Materials. You will be part of the Facility & Equipment team consisting of 9 Quality Assurance professionals. The Team is responsible for assignments at the API pilot facilities assuring the quality of the facility and the Equipment.
In the department, we value teamwork, diversity, and humour very high, and we will make sure that you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor.
Contact
For further information, please contact Associate Manager Charlotte Hellesøe Ørtoft +45 3075 1742 or Sr. QA professional Tine Harboe Wolf +45 3079 3795
Deadline
7th of January 2023. Applications will be reviewed ongoing. Interviews are held continuously, and employment can thus potentially take place before the deadline.
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.
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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 22.11.2022, 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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