Aseptic production QA Specialist
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Kalundborg
Are you passionate about making a difference in the lives of patients with chronic diseases? Do you want to be a key player in ensuring the highest quality standards and patient safety in the biotech and the rare disease industry at Novo Nordisk? If so, this is the perfect opportunity for you.
As a QA professional in our Aseptic Production team, you will play a crucial role in ensuring that our products meet the ever-increasing demand of regulatory authorities and compliance requirements. You will be responsible for overseeing the entire production process, including formulation, sterilization, filling, and inspection, to ensure that our products are of the highest quality and patient safety is maintained. You will be working in one of the most exciting, dynamic, and complex areas of Novo Nordisk, and will have the opportunity to undergo a structured and individualized program. You will also have an individual development plan to ensure continuous growth and the realization of your potential. The position
We are looking for experienced candidates who are eager to use their strong quality mindset and great interpersonal skills to ensure products of the highest quality to serve our patients. As releasing QA professional, it is our overall responsibility to set direction for quality and compliance based on the ever-increasing demands of the authorities and requirements we comply with. You must therefore help to ensure the solutions that integrate quality and compliance with good optimizations in production. Thus, QA oversight is a huge part of our job both during the aseptic filling, release of products and review of several types of documents. The quality oversight covers a broad range of processes within formulation, wash and sterilisation processes, filling, freeze-drying and visual inspection. QA are present in the production area every day which requires good cooperation and a solution-focused dialogue with both stakeholders and QA colleagues.
We strive for effective review and approval process to ensure that we get products out to our patients at the best quality and in a timely manner. When joining our team, you will undergo a structured and individual training program, and you can expect increasingly more responsibility. Subsequently, you will have an individual development plan to ensure continuous development and realization of your potential. Qualifications
Our thoughts about what our new colleague should be like:
If you do have three or more years’ experience with aseptic filling from production or QA in the pharmaceutical industry it will be an advantage. You hold a degree in pharmacy, engineering, veterinary science, or other relevant MSc in education as it is important that you meet the Danish Medicines Agency's requirements for "Qualified Person" as you will obtain QP delegate responsibility as part of the job. You have good collaboration and communication skills - you thrive in communicating clearly and effectively to stakeholders in a good tone, even when the message is not easy. At the same time, we expect you to value good colleagues and contribute positively to a good working environment.
It is important that you thrive in a role where you are required to make independent decisions and being part of improving our high standards, including ensuring that the ways of working are challenged appropriately. You know and meet deadlines and you are capable of prioritizing between different tasks - also in a busy environment where priorities quickly can be changed for the benefit of patients, compliance to requirements or business conduct. Finally, we operate in an international company, and the position, therefore, requires proficiency in English and Danish. About the department
We are a dynamic and well-functioning department with many interfaces around the organization including production, management, and other QA departments. We love professional challenges and work independently with great individual responsibility, while a high level of commitment and good socializing is in focus – it must be fun and challenging to go to work. We are 47 employees in the department, where you will be part of a team consisting of 9 highly skilled and competent colleagues. You will become part of an ambitious team with good humour in a casual atmosphere and where we take care of each other. We are open and honest and appreciate a colleague who takes responsibility and have a positive approach to new challenges. 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 Associate manager Kristine Helander Jensen +45 30 75 49 90. Deadline
6th of February 2023 You may submit your application in English or in Danish. We will review applications received on an ongoing basis, so do not hesitate to apply today. 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.
As a QA professional in our Aseptic Production team, you will play a crucial role in ensuring that our products meet the ever-increasing demand of regulatory authorities and compliance requirements. You will be responsible for overseeing the entire production process, including formulation, sterilization, filling, and inspection, to ensure that our products are of the highest quality and patient safety is maintained. You will be working in one of the most exciting, dynamic, and complex areas of Novo Nordisk, and will have the opportunity to undergo a structured and individualized program. You will also have an individual development plan to ensure continuous growth and the realization of your potential. The position
We are looking for experienced candidates who are eager to use their strong quality mindset and great interpersonal skills to ensure products of the highest quality to serve our patients. As releasing QA professional, it is our overall responsibility to set direction for quality and compliance based on the ever-increasing demands of the authorities and requirements we comply with. You must therefore help to ensure the solutions that integrate quality and compliance with good optimizations in production. Thus, QA oversight is a huge part of our job both during the aseptic filling, release of products and review of several types of documents. The quality oversight covers a broad range of processes within formulation, wash and sterilisation processes, filling, freeze-drying and visual inspection. QA are present in the production area every day which requires good cooperation and a solution-focused dialogue with both stakeholders and QA colleagues.
We strive for effective review and approval process to ensure that we get products out to our patients at the best quality and in a timely manner. When joining our team, you will undergo a structured and individual training program, and you can expect increasingly more responsibility. Subsequently, you will have an individual development plan to ensure continuous development and realization of your potential. Qualifications
Our thoughts about what our new colleague should be like:
We are a dynamic and well-functioning department with many interfaces around the organization including production, management, and other QA departments. We love professional challenges and work independently with great individual responsibility, while a high level of commitment and good socializing is in focus – it must be fun and challenging to go to work. We are 47 employees in the department, where you will be part of a team consisting of 9 highly skilled and competent colleagues. You will become part of an ambitious team with good humour in a casual atmosphere and where we take care of each other. We are open and honest and appreciate a colleague who takes responsibility and have a positive approach to new challenges. 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 Associate manager Kristine Helander Jensen +45 30 75 49 90. Deadline
6th of February 2023 You may submit your application in English or in Danish. We will review applications received on an ongoing basis, so do not hesitate to apply today. 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kalundborg.
Jobbet er oprettet på vores service den 17.1.2023, 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.
- Øvrige
- Kalundborg
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