QA Specialist in Aseptic Production
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Are you seeking new opportunities and have ambitions to take up new challenges for your career? Are you ready to support the exciting project expansion at Site Bagsværd within the filling process to implement new isolator lines and be part of a dynamic high performing Quality Assurance (QA) Project Team? Then this position could be the right match for you. At Injectable Finished Products (IFP) QA Bagsværd we are responsible for quality assurance of the aseptic production in Bagsværd. It is our responsibility to ensure that the documentation meets the regulatory GMP (Good Manufacturing Practice) requirements. IFP QA Bagsværd consists of 60 dedicated and engaged employees who are divided into four different teams – Operations, AP (Aseptic Production) release, QA release and Project Qualification team. We are looking for a new colleague to join our Project Qualification Team as a QA Specialist who has the maturity and experience to set direction for the quality assurance of the future isolators at Site Bagsværd. The position You are the QA Specialist acting as the lead quality responsible in the initial stages starting up a new project at Site Bagsværd to expand into the future new isolators. You will work in direct collaboration with the site project team across the different disciplines. It is important to drive the direction and clarity to set the cGMP foundation in the plans for the new Bagsværd facility. Your key responsibility is to ensure QA oversight in the validation of production processes with regards to the future isolators, as well as qualification of facilities, equipment and automation systems is documented according to current GMP requirements. You will do this by involvement and participation in workshops and discussions with both the project team and production colleagues, especially with regards to the implementation of the future isolators in production. In this QA Specialist role, you will be the lead voice in setting quality directions. This demands strong interpersonal skills and a solution-oriented approach when collaborating with colleagues both in the production and QA through open and honest dialogue. We work together as a team with a desire to solve challenges through open and honest dialogue. We always work on improving our way of working and we appreciate innovative ideas and continuous improvements. In this job you will get the opportunity to make an impact for our patients as we increase our production capacity for the benefit of our patients. Qualifications To succeed in this role, you have: a master’s degree within pharmacy, engineering or similar 5+ years of experience working with processes from aseptic production or quality hands on experience with risk assessment, validation and qualification of production equipment, product, and/or IT Systems a solid and up-to date knowledge of quality and GMP requirements excellent stakeholder management and communication skills fluency in English and preferably have a good Danish proficiency too knowledge/experience in isolator technology would be an advantage
As a person it is natural for you to solve challenges in collaboration with colleagues and seek feedback on your assignments to ensure the best possible solution. You have a robust, structured, self-starter and a great collaborator always having a positive attitude. You have the right quality mindset, able to balance and set things in perspective and see the big picture. You are open, honest, and inclusive regarding your QA and production colleagues, and enjoy working in a dynamic environment where you can take responsibility. Working at Novo Nordisk At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, contact Thinnakone Arounsack-Jørgensen on +45 3079 6154. Deadline 25 Aug 2023. Feel free to submit your application in Danish or English. Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate has been identified. 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 person it is natural for you to solve challenges in collaboration with colleagues and seek feedback on your assignments to ensure the best possible solution. You have a robust, structured, self-starter and a great collaborator always having a positive attitude. You have the right quality mindset, able to balance and set things in perspective and see the big picture. You are open, honest, and inclusive regarding your QA and production colleagues, and enjoy working in a dynamic environment where you can take responsibility. Working at Novo Nordisk At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, contact Thinnakone Arounsack-Jørgensen on +45 3079 6154. Deadline 25 Aug 2023. Feel free to submit your application in Danish or English. Please note that applications will be reviewed continuously, and interviews will be planned as soon as a suitable candidate has been identified. 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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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 1.8.2023, 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.
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