Experienced QA professional for manufacturing development
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Gentofte
Are you motivated to make a difference and strive for simplicity? Do you want to play a crucial role in ensuring quality and patient safety within Quality Assurance (QA) in Biotech and Rare Disease (BRD) to benefit patients with a wide range of chronic diseases? If so, this position can be a unique opportunity for you.
The position
As QA, our key task is to ensure products of the highest quality to serve our patients. It is crucial that the products are filed, produced, analysed, and released in full compliance with current practice and guidelines from authorities. The working assignments are versatile and cover the review and approval of several types of GMP documentation, oversight of quality processes through presence in the facilities and setting direction on quality issues.
Your main responsibilities and tasks will include:
Qualifications
You have a Master degree in pharmacy, microbiology, chemical engineering or similar, and 3+ years of experience with the pharmaceutical industry. You have solid English and Danish skills, both verbally and in writing.
As a person you find it easy to take responsibility, work independently, and make decisions that balance quality demands, authority expectations, and business needs. You are flexible and have a strong quality mind-set combined with the ability to increase simplicity. It comes natural for you to communicate, and you know how to communicate clearly in a good tone, even when the message is not easy. And you have good coordinating- and collaboration skills when handling cases with both colleagues and stakeholders. Finally, you have a curious, innovative, and solution-oriented approach to overcoming challenges.
About the department
The department counts 28 employees and consists of three teams, and you will join a group of very experienced colleagues. The teams have a high level of self-governance, and our working relations are informal. We value good humour, an open and honest culture. We appreciate a colleague who takes responsibility, has a positive and curious approach to new challenges, contributes to a great working atmosphere, as we are convinced that this is the key to create good results.
You will become part of Biotech & Rare Diseases (BRD) QA QC, MDev and support, which is a dynamic and well-functioning department with many interfaces and stakeholders around the organisation.
The three teams are supporting Quality Control (QC) laboratories, manufacture development and support which are highly involved in the core of quality processes and authority inspections. Our department is an integrated part of projects concerning digitalization, innovation, and automation, providing the opportunity to impact the future state of the organisation.
Working in Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.
Contact
If you want to know more about the position, please contact Associate Manager Line Lilleøre +45 30798581.
Deadline
20 November 2022
Feel free to submit your application in Danish or English. Please note that applications will be reviewed continuously, so we encourage you to apply as soon as possible.
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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The position
As QA, our key task is to ensure products of the highest quality to serve our patients. It is crucial that the products are filed, produced, analysed, and released in full compliance with current practice and guidelines from authorities. The working assignments are versatile and cover the review and approval of several types of GMP documentation, oversight of quality processes through presence in the facilities and setting direction on quality issues.
Your main responsibilities and tasks will include:
- Implementation of early stage products
- Cover product life cycle
- Stability studies and submission to regulatory authorities
- Science and Risk-based validation, change requests, deviations, SOPs etc.
- Facilities include pilot plants for support proteins and matrices
- Batch documentation and status assignment for support proteins
- Development laboratories and climate facilities
- Participate in process groups and Chemistry, manufacture and control (CMC) groups
Qualifications
You have a Master degree in pharmacy, microbiology, chemical engineering or similar, and 3+ years of experience with the pharmaceutical industry. You have solid English and Danish skills, both verbally and in writing.
As a person you find it easy to take responsibility, work independently, and make decisions that balance quality demands, authority expectations, and business needs. You are flexible and have a strong quality mind-set combined with the ability to increase simplicity. It comes natural for you to communicate, and you know how to communicate clearly in a good tone, even when the message is not easy. And you have good coordinating- and collaboration skills when handling cases with both colleagues and stakeholders. Finally, you have a curious, innovative, and solution-oriented approach to overcoming challenges.
About the department
The department counts 28 employees and consists of three teams, and you will join a group of very experienced colleagues. The teams have a high level of self-governance, and our working relations are informal. We value good humour, an open and honest culture. We appreciate a colleague who takes responsibility, has a positive and curious approach to new challenges, contributes to a great working atmosphere, as we are convinced that this is the key to create good results.
You will become part of Biotech & Rare Diseases (BRD) QA QC, MDev and support, which is a dynamic and well-functioning department with many interfaces and stakeholders around the organisation.
The three teams are supporting Quality Control (QC) laboratories, manufacture development and support which are highly involved in the core of quality processes and authority inspections. Our department is an integrated part of projects concerning digitalization, innovation, and automation, providing the opportunity to impact the future state of the organisation.
Working in Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.
Contact
If you want to know more about the position, please contact Associate Manager Line Lilleøre +45 30798581.
Deadline
20 November 2022
Feel free to submit your application in Danish or English. Please note that applications will be reviewed continuously, so we encourage you to apply as soon as possible.
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 Gentofte.
Jobbet er oprettet på vores service den 27.10.2022, 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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