Advanced QA professional in CMC analysis QA
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Måløv
Are you ready to ensure compliance and high quality in development laboratories and analytical project activities? Would you thrive by working with skilled colleagues known for their fantastic team spirit? Then, come working with us in Måløv. The position
In close cooperation with colleagues, you will act as QA for our analytical development departments. Your main responsibility will be to quality assure the laboratories. Thereby contribute to the products are of high standards and in full compliance with the current rules and guidelines.
Also, you will be responsible for: Approving method qualification and validation documentation from CMC analytical departments and contract manufacturers (CMOs) for the release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials. Providing consultation on analytical topics for various development projects, applying a risk-based approach to development processes and products. Finding the right balance between patient safety, compliance to requirements, and effective business conduct in the development process. Approving of qualification and validation documentation for laboratory equipment. Qualifications
To succeed in this role, you should: Hold an academic degree as pharmacist, veterinary medicine, engineer, biochemist or similar. Have at least 3 years’ experience from a pharmaceutical organisation, preferable within quality assurance or quality control, where you have gained a solid and up-to-date knowledge of quality and Good Manufacturing Practice (GMP) requirements. Ideally, possess a solid knowledge within validation of analytical methods and equipment qualification. Possess excellent communication skills, as you will need to effectively communicate complex content to people with different backgrounds and skills. Fluent in Danish and English as proficiency in both languages is required. As person you are open-minded with an outgoing attitude and natural networking skills. You contribute positively to our team and enjoy working with people from different professional backgrounds who are dedicated towards our common goal. You are eager to see things moving forward in a dynamic environment with changing priorities, which requires flexibility and ability to organize and drive tasks forward. Thus, making an impact with your ideas and suggestions. You take a pragmatic approach to problem solving and have a strong quality mind set.
Additionally, we would enjoy having a straightforward person with sense of humor in our department. About the department
We are a well-functional and a very harmonious social team.
is going into digital improvements and seeking a new colleague to help us support this transition. We are 10 dedicated colleagues ensuring that the laboratories and their analysis activities for all development projects live up to cGMP requirements.
We continuing to make sure that high level of audit and inspection readiness is on top on our agenda. Therefore, we work with QA oversight where we proactively will identify areas where compliance can be strengthened, and we can work smarter with digital solutions and automated processes. You will develop a broad knowledge of all analytical methods involved in testing clinical products and you will work in close collaboration with main stakeholder departments to identify opportunities for optimizations and simplifications. Working at
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. relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Manager Stine Marie Faaborg +. Deadline
13 August 2024.
You may submit your application in English or in Danish.
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 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.
In close cooperation with colleagues, you will act as QA for our analytical development departments. Your main responsibility will be to quality assure the laboratories. Thereby contribute to the products are of high standards and in full compliance with the current rules and guidelines.
Also, you will be responsible for:
To succeed in this role, you should:
Additionally, we would enjoy having a straightforward person with sense of humor in our department. About the department
We are a well-functional and a very harmonious social team.
is going into digital improvements and seeking a new colleague to help us support this transition. We are 10 dedicated colleagues ensuring that the laboratories and their analysis activities for all development projects live up to cGMP requirements.
We continuing to make sure that high level of audit and inspection readiness is on top on our agenda. Therefore, we work with QA oversight where we proactively will identify areas where compliance can be strengthened, and we can work smarter with digital solutions and automated processes. You will develop a broad knowledge of all analytical methods involved in testing clinical products and you will work in close collaboration with main stakeholder departments to identify opportunities for optimizations and simplifications. Working at
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. relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Manager Stine Marie Faaborg +. Deadline
13 August 2024.
You may submit your application in English or in Danish.
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 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 30.7.2024, 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
- Måløv
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