QA Professional in Aseptic Production
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Ready for an exciting new opportunity in quality assurance? Join our dynamic team at IFP QA Site Bagsværd aseptic production and make a difference in the lives of patients! Our team of highly skilled professionals is dedicated to ensuring the highest standards of quality and safety in our pharmaceutical products. This is your chance to work on exciting projects, make meaningful contributions to our business, and join our Quality community. The job
We are responsible for quality assurance of the aseptic production at Injectable Finished Products (IFP) QA, Bagsværd. It is our responsibility to ensure that the documentation meets the regulator GMP requirements. The department consists of 50 dedicated and engaged employees who are divided into four different teams – Operations, AP release, QA release and Project Qualification team. We are looking for a new colleague to join our Project Qualification Team.
Your key responsibility is to ensure that validation of production processes, as well as qualification of facilities, equipment and automation systems is documented according to current GMP requirements. You will do this by involvement in investment and optimization projects, as well as daily support to production. Your daily tasks will also include approval of deviations, change requests, risk assessments, and SOPs. As QA, you will perform QA presence requiring physical present on the production area to observe and help solve potential issues in real time. Also, you will perform QA oversight by participating in workshops and discussions alongside our colleagues in the production. In the QA professional role, you will have broad contact with production in setting quality directions. This demands strong interpersonal skills and 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 new ideas and continues improvements. In this job you will get the opportunity to make an impact for our patients as we release products to the marketed for benefit for our patients. Qualifications
To succeed in this role, we imagine that you have: • A Master´s degree in Engineering, Pharmacy or corresponding education (for example MSc. Biochemistry or Operation and Maintenance Engineering)
• A minimum 3+ years of experience from QA or pharmaceutical production
• Proficiency in English and Danish, written and oral. It is an advantage if you have technical knowledge regarding aseptic production equipment and automation, as well as experience with risk assessment and qualification /validation.
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 the right quality mindset, dare to challenge our way of working and are known for your ability to identify improvements, as well as taking the lead for driving the implementation of these improvements. You are open, honest, and inclusive regarding your QA and production colleagues, and enjoy working in a dynamic environment where you can take responsibility. You are ambitious and ready to be part of our on-going effort to improve our high standards, including ensuring new ways of working are implemented smoothly. 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
June 11th 2023
Applications will be evaluated continuously, and candidates may be called for an interview before the deadline, so please apply as soon as you can. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Additionally, please avoid the use of photos in your CV. This provides a better and more fair process. 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.
We are responsible for quality assurance of the aseptic production at Injectable Finished Products (IFP) QA, Bagsværd. It is our responsibility to ensure that the documentation meets the regulator GMP requirements. The department consists of 50 dedicated and engaged employees who are divided into four different teams – Operations, AP release, QA release and Project Qualification team. We are looking for a new colleague to join our Project Qualification Team.
Your key responsibility is to ensure that validation of production processes, as well as qualification of facilities, equipment and automation systems is documented according to current GMP requirements. You will do this by involvement in investment and optimization projects, as well as daily support to production. Your daily tasks will also include approval of deviations, change requests, risk assessments, and SOPs. As QA, you will perform QA presence requiring physical present on the production area to observe and help solve potential issues in real time. Also, you will perform QA oversight by participating in workshops and discussions alongside our colleagues in the production. In the QA professional role, you will have broad contact with production in setting quality directions. This demands strong interpersonal skills and 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 new ideas and continues improvements. In this job you will get the opportunity to make an impact for our patients as we release products to the marketed for benefit for our patients. Qualifications
To succeed in this role, we imagine that you have: • A Master´s degree in Engineering, Pharmacy or corresponding education (for example MSc. Biochemistry or Operation and Maintenance Engineering)
• A minimum 3+ years of experience from QA or pharmaceutical production
• Proficiency in English and Danish, written and oral. It is an advantage if you have technical knowledge regarding aseptic production equipment and automation, as well as experience with risk assessment and qualification /validation.
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 the right quality mindset, dare to challenge our way of working and are known for your ability to identify improvements, as well as taking the lead for driving the implementation of these improvements. You are open, honest, and inclusive regarding your QA and production colleagues, and enjoy working in a dynamic environment where you can take responsibility. You are ambitious and ready to be part of our on-going effort to improve our high standards, including ensuring new ways of working are implemented smoothly. 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
June 11th 2023
Applications will be evaluated continuously, and candidates may be called for an interview before the deadline, so please apply as soon as you can. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Additionally, please avoid the use of photos in your CV. This provides a better and more fair process. 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 Bagsværd.
Jobbet er oprettet på vores service den 15.5.2023, 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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