Qualification Supporter
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Måløv
Are you passionate about compliance and qualification support for production equipment? Are you eager to be part of Novo Nordisk’s major quest within tablets and do you want to influence a department working with processes on the edge of the future?
You will be joining a great team followed by great career opportunities, so read more and apply now to be our new Qualification Supporter! About the department
Emerging Technology (ET) Oral Products Development (OPDev) is an area within Product Supply Quality & IT, organised in eight departments and based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I and II covering a broad and exciting range of process technologies for solid dosage forms. ET OPDev Technical Support department consists of three teams.
We are currently expanding our Equipment & Facility team, consisting of 18 dedicated colleagues all contributing to sustain our “License to operate”. Our main responsibility is qualification of equipment, facility monitoring, maintenance & calibration, which allows us to produce in compliance with GMP standards. The position
As a Qualification Supporter, you will play a key role in our business-critical efforts to ensure and maintain the facility’s license to operate. Your focus will be on:
• Preparing, reviewing, and approving GMP documents, including Standard Operation Procedures and System evaluations
• Minor qualification documents
• Minor Change Requests and Deviations
• De-commissioning of equipment
• Order, handling and like-to-like replacement of spare parts
• Participate in Ready For Production in regards to handover from Development to GMP production You will be working closely together with Engineering Responsible’ s in the team as well as other relevant stakeholders both internally and externally. Qualifications
In order to become a success in this role, we believe that your profile should be aligned with the bullets listed below. However, we acknowledge that success can take many forms, so please do apply even if you do not tick all the boxes. You: • Have either an academic degree or a diploma paired with relevant work experience
• Have gained practical experience in GMP regulation or at least have proven theoretical knowledge on it
• Preferably have experience as equipment/qualification responsible in a pharmaceutical setting
• Have a structured way of working and preferably a LEAN mindset
• Have excellent communication skills in both Danish and English
Knowledge within solid dosage forms may be an advantage but it’s not a prerequisite.
On a personal level, you have a positive can-do attitude and thrive in an everchanging environment. You connect easily with all organisational levels due to your excellent communication and people skills. You can quickly create an overview over possible solutions, consequences and needed compromises and you have a passion for setting structure and standards.
We look forward to welcome you, in our team!
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Associate Manager Charlotte Helene Riggelsen at [email protected] Please note that due to vacation season you should not be expecting a response from Charlotte or Talent Acquisition prior to August the 8th 2023. Deadline
6 August 2023 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.
You will be joining a great team followed by great career opportunities, so read more and apply now to be our new Qualification Supporter! About the department
Emerging Technology (ET) Oral Products Development (OPDev) is an area within Product Supply Quality & IT, organised in eight departments and based in Måløv. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I and II covering a broad and exciting range of process technologies for solid dosage forms. ET OPDev Technical Support department consists of three teams.
We are currently expanding our Equipment & Facility team, consisting of 18 dedicated colleagues all contributing to sustain our “License to operate”. Our main responsibility is qualification of equipment, facility monitoring, maintenance & calibration, which allows us to produce in compliance with GMP standards. The position
As a Qualification Supporter, you will play a key role in our business-critical efforts to ensure and maintain the facility’s license to operate. Your focus will be on:
• Preparing, reviewing, and approving GMP documents, including Standard Operation Procedures and System evaluations
• Minor qualification documents
• Minor Change Requests and Deviations
• De-commissioning of equipment
• Order, handling and like-to-like replacement of spare parts
• Participate in Ready For Production in regards to handover from Development to GMP production You will be working closely together with Engineering Responsible’ s in the team as well as other relevant stakeholders both internally and externally. Qualifications
In order to become a success in this role, we believe that your profile should be aligned with the bullets listed below. However, we acknowledge that success can take many forms, so please do apply even if you do not tick all the boxes. You: • Have either an academic degree or a diploma paired with relevant work experience
• Have gained practical experience in GMP regulation or at least have proven theoretical knowledge on it
• Preferably have experience as equipment/qualification responsible in a pharmaceutical setting
• Have a structured way of working and preferably a LEAN mindset
• Have excellent communication skills in both Danish and English
Knowledge within solid dosage forms may be an advantage but it’s not a prerequisite.
On a personal level, you have a positive can-do attitude and thrive in an everchanging environment. You connect easily with all organisational levels due to your excellent communication and people skills. You can quickly create an overview over possible solutions, consequences and needed compromises and you have a passion for setting structure and standards.
We look forward to welcome you, in our team!
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information, please contact Associate Manager Charlotte Helene Riggelsen at [email protected] Please note that due to vacation season you should not be expecting a response from Charlotte or Talent Acquisition prior to August the 8th 2023. Deadline
6 August 2023 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 Måløv.
Jobbet er oprettet på vores service den 7.7.2023, 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
- Måløv
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