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 in the process of releasing Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials? Would you thrive by working with skilled colleagues known for their fantastic team spirit?
If yes, then read on and apply for a life-changing career! 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.
You will approve method qualification and validation documentation from Chemistry, Manufacturing and Control (CMC) analytical departments and contract manufactures (CMOs) in the process of release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials.
You will work and be consulted in various development projects on analytical topics and be expected to have a risk-based approach to the development process and product. In connection to this you find the right balance between patient safety, compliance to requirements and effective business conduct. In addition, the job also includes approval of qualification and validation documentation for laboratory equipment.
Qualifications
To succeed in this role, you have:
• Academic degree as pharmacist, veterinary medicine, engineer, biochemist or similar
• 2-3 years’ experience from a pharmaceutical organization, preferable within quality assurance or quality control
• Ideally solid knowledge within validation of analytical methods and equipment qualification
• Solid and up-to-date knowledge of quality and Good Manufacturing Practice (GMP) requirements
• Good communication skills are a must, and you can communicate complex content to people with different backgrounds and skills
• Fluency in Danish and English
As a person, 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, initiative, 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. About the department
The team is part of the CMC OP Dev QA department. We are a well-functional and very harmonious team of 10 dedicated colleagues ensuring that the laboratories and their analytical activities for all development projects live up to cGMP requirements.
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 within analytical methods involved in testing of clinical products and you will work in close collaboration with our stakeholder departments.
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 at
Deadline
22 March 2024
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.
If yes, then read on and apply for a life-changing career! 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.
You will approve method qualification and validation documentation from Chemistry, Manufacturing and Control (CMC) analytical departments and contract manufactures (CMOs) in the process of release of Active Pharmaceutical Ingredients (API) and Drug Product (DP) for clinical trials.
You will work and be consulted in various development projects on analytical topics and be expected to have a risk-based approach to the development process and product. In connection to this you find the right balance between patient safety, compliance to requirements and effective business conduct. In addition, the job also includes approval of qualification and validation documentation for laboratory equipment.
Qualifications
To succeed in this role, you have:
• Academic degree as pharmacist, veterinary medicine, engineer, biochemist or similar
• 2-3 years’ experience from a pharmaceutical organization, preferable within quality assurance or quality control
• Ideally solid knowledge within validation of analytical methods and equipment qualification
• Solid and up-to-date knowledge of quality and Good Manufacturing Practice (GMP) requirements
• Good communication skills are a must, and you can communicate complex content to people with different backgrounds and skills
• Fluency in Danish and English
As a person, 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, initiative, 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. About the department
The team is part of the CMC OP Dev QA department. We are a well-functional and very harmonious team of 10 dedicated colleagues ensuring that the laboratories and their analytical activities for all development projects live up to cGMP requirements.
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 within analytical methods involved in testing of clinical products and you will work in close collaboration with our stakeholder departments.
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 at
Deadline
22 March 2024
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 1.3.2024, 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.
- 22.04.2024
- Øvrige
- Måløv
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