QA Professional
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Kalundborg
Can you quickly grasp and adapt to new challenges? Do you have the ability to distinguish between what is essential and what is adequate? Are you keen on working in a focused environment with highly skilled colleagues and assuming responsibility for guiding quality in a fast-paced production setting?
If so, we could be your new colleagues. Apply now and join our team! The Position
As our new colleague, you will help ensure the quality of M1 at Novo Nordisk in Kalundborg and get to cooperate closely with the production departments. Our team works primarily with the departments for Purification, Environmental Monitoring, IT and for the execution of projects. You will be handling one or more of these areas, depending on your wishes and competencies. We focus on patient safety in the interpretation, dissemination and implementation of regulatory requirements, compliance signals and local requirements in all relevant tasks and documents. The position requires a high degree of independence as well as strong communication and collaboration skills. Your responsibilities will include:
• Driving quality direction and oversight.
• Approving, among other things, documents from stakeholders (deviations, change requests, batch, trend, and validation/qualification reports).
• Ensuring that the products leaving M1 are ready for our patients in terms of quality.
• Preparing Annual Product and Specifications Reviews.
• Participating in cross-cutting process group work.
• Engaging in go-look-see in connection with systematic problem solving.
• Exercising QA presence on running production to ensure continuous improvements and prevent future errors.
Qualifications
We are looking for a dedicated colleague with strong collaborations skills capable of working independently and within teams. To thrive and succeed in this role, you should have:
• A master’s degree in pharmacy, engineering, biology or equivalent.
• Fulfilling the requirements to become a “Qualified Person” (QP), according to The Danish Medicines Agency certification, would be an advantage.
• Good communication skills, Fluent in Danish and English – oral and written.
• It will be an advantage (but not a requirement) with production, project or QA experience from the pharmaceutical industry and your title and salary will reflect your experience/competence level. As a person you are proactive, meeting deadlines and taking responsibility for your tasks. Your structured approach allows you to maintain clarity, even in a fast-paced, changing environment. You embrace change and are open to challenging and improving our work processes. Your positive attitude and sense of humor contribute to a productive work environment. About the department
Our department consists of a staff team as well as three QA teams. Our team 351.02 consists of 16 QA professionals and an associate manager. We support M1, still the largest API factory in Denmark. There are more than 600 employees here and we are responsible for producing several of Novo Nordisk's newest and most coveted active substances. Our ambition is to be a competent, solution-oriented, and experienced sparring partner for our stakeholders in production, so that our common goal of ensuring the quality of our patients is met. We can offer you an exciting and challenging job with committed colleagues in a changing environment. A well-functioning team, where we focus on internal sparring, alignment, and work / life balance. We can offer involvement in projects, if/when you have the competencies needed. We know that you will develop both your professional and personal competencies, and that you will contribute to the next stage of Novo Nordisk's success story. More than 90 years of innovation and leadership have placed us in world-class within e.g., diabetes, and we are constantly working to maintain and expand our position so that even more people can access our life-changing products.
Working in 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 Manager Jannie Gregers, Phone +45 30792413 between 10 am and 20 pm. Deadline
5 May 2024. Please be advised that interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible.
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.
If so, we could be your new colleagues. Apply now and join our team! The Position
As our new colleague, you will help ensure the quality of M1 at Novo Nordisk in Kalundborg and get to cooperate closely with the production departments. Our team works primarily with the departments for Purification, Environmental Monitoring, IT and for the execution of projects. You will be handling one or more of these areas, depending on your wishes and competencies. We focus on patient safety in the interpretation, dissemination and implementation of regulatory requirements, compliance signals and local requirements in all relevant tasks and documents. The position requires a high degree of independence as well as strong communication and collaboration skills. Your responsibilities will include:
• Driving quality direction and oversight.
• Approving, among other things, documents from stakeholders (deviations, change requests, batch, trend, and validation/qualification reports).
• Ensuring that the products leaving M1 are ready for our patients in terms of quality.
• Preparing Annual Product and Specifications Reviews.
• Participating in cross-cutting process group work.
• Engaging in go-look-see in connection with systematic problem solving.
• Exercising QA presence on running production to ensure continuous improvements and prevent future errors.
Qualifications
We are looking for a dedicated colleague with strong collaborations skills capable of working independently and within teams. To thrive and succeed in this role, you should have:
• A master’s degree in pharmacy, engineering, biology or equivalent.
• Fulfilling the requirements to become a “Qualified Person” (QP), according to The Danish Medicines Agency certification, would be an advantage.
• Good communication skills, Fluent in Danish and English – oral and written.
• It will be an advantage (but not a requirement) with production, project or QA experience from the pharmaceutical industry and your title and salary will reflect your experience/competence level. As a person you are proactive, meeting deadlines and taking responsibility for your tasks. Your structured approach allows you to maintain clarity, even in a fast-paced, changing environment. You embrace change and are open to challenging and improving our work processes. Your positive attitude and sense of humor contribute to a productive work environment. About the department
Our department consists of a staff team as well as three QA teams. Our team 351.02 consists of 16 QA professionals and an associate manager. We support M1, still the largest API factory in Denmark. There are more than 600 employees here and we are responsible for producing several of Novo Nordisk's newest and most coveted active substances. Our ambition is to be a competent, solution-oriented, and experienced sparring partner for our stakeholders in production, so that our common goal of ensuring the quality of our patients is met. We can offer you an exciting and challenging job with committed colleagues in a changing environment. A well-functioning team, where we focus on internal sparring, alignment, and work / life balance. We can offer involvement in projects, if/when you have the competencies needed. We know that you will develop both your professional and personal competencies, and that you will contribute to the next stage of Novo Nordisk's success story. More than 90 years of innovation and leadership have placed us in world-class within e.g., diabetes, and we are constantly working to maintain and expand our position so that even more people can access our life-changing products.
Working in 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 Manager Jannie Gregers, Phone +45 30792413 between 10 am and 20 pm. Deadline
5 May 2024. Please be advised that interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible.
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 19.4.2024, 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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