QA Professional
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Måløv
QA professional with raw material expertise Are you up for a role where you will be ensuring compliance and high quality in all raw materials used for cell therapy products in future clinical trials? Are you driven by a passion of contributing to secure patient safety? Are you looking to work with a new and exciting area and therapy area within Novo Nordisk? If so, we have an exciting opportunity waiting for you as our new colleague in Chemistry, Manufacturing and Control (CMC) QA! The position
As our new QA Professional, you will be working in both Måløv and Bagsværd. Furthermore, travel days can be expected when working with our international Contract Manufacturing Organisations (CMOs) and suppliers. You will support the Stem Cell area incl. raw material team and ensure compliance to cGMP requirements. In your daily work you will approve raw materials for clinical use, author quality agreements documents and approve different development documents. In collaboration with colleagues and stakeholders, you will contribute to establish the Quality Management System (QMS) for phase 3 cell therapy products as well as strengthening the quality and compliance level in the research unit. Approval of deviations and change request as well as batch review will, also be a part of your job. Qualifications
You have a solid understanding of the important aspects of regulations, requirements and guidelines for raw material, pharmaceutical development and/or aseptic production, and hence you know how to manoeuvre without adding unnecessary complexity. You have a pragmatic approach to problem-solving and a strong quality mindset. We imagine the ideal candidate has: • An academic degree as a biologist, pharmacist, engineer, or similar
• Approx. three years’ experience from a pharmaceutical company, preferable within quality assurance, raw materials or in aseptic production
• Solid and up-to date knowledge of quality and Good Manufacturing Processes (GMP) requirements
• Understanding of regulations, requirements and guidelines in pharmaceutical development
• Strong communication skills and ability to translate complex content
• Fluent in Danish and English On a personal level, you are straightforward, eager to see things moving in a dynamic environment where projects and processes vary, requiring flexibility and skills to organise and drive tasks. You are self-driven and independent with a high sense of responsibility and initiative, and you know how to prioritise your many different tasks. You are a team player with great interpersonal skills because teamwork and collaboration are on the top of our agenda. About the department
You will become part of a department consisting of three teams where we currently are around 30 dedicated colleagues. The open position is in the newly established team CMC QA Cell Therapy consisting of 4 skilled operational QA professionals. Our main purpose is to safeguard patient safety and ensure product quality and compliance. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, in order to ensure Novo Nordisk’s critical delivery of medicines to patients. 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 Marianne Mørch Hansen +45 3079 8154. Deadline
31st of May. Applications will be screened on an ongoing basis, so you are encouraged 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.
As our new QA Professional, you will be working in both Måløv and Bagsværd. Furthermore, travel days can be expected when working with our international Contract Manufacturing Organisations (CMOs) and suppliers. You will support the Stem Cell area incl. raw material team and ensure compliance to cGMP requirements. In your daily work you will approve raw materials for clinical use, author quality agreements documents and approve different development documents. In collaboration with colleagues and stakeholders, you will contribute to establish the Quality Management System (QMS) for phase 3 cell therapy products as well as strengthening the quality and compliance level in the research unit. Approval of deviations and change request as well as batch review will, also be a part of your job. Qualifications
You have a solid understanding of the important aspects of regulations, requirements and guidelines for raw material, pharmaceutical development and/or aseptic production, and hence you know how to manoeuvre without adding unnecessary complexity. You have a pragmatic approach to problem-solving and a strong quality mindset. We imagine the ideal candidate has: • An academic degree as a biologist, pharmacist, engineer, or similar
• Approx. three years’ experience from a pharmaceutical company, preferable within quality assurance, raw materials or in aseptic production
• Solid and up-to date knowledge of quality and Good Manufacturing Processes (GMP) requirements
• Understanding of regulations, requirements and guidelines in pharmaceutical development
• Strong communication skills and ability to translate complex content
• Fluent in Danish and English On a personal level, you are straightforward, eager to see things moving in a dynamic environment where projects and processes vary, requiring flexibility and skills to organise and drive tasks. You are self-driven and independent with a high sense of responsibility and initiative, and you know how to prioritise your many different tasks. You are a team player with great interpersonal skills because teamwork and collaboration are on the top of our agenda. About the department
You will become part of a department consisting of three teams where we currently are around 30 dedicated colleagues. The open position is in the newly established team CMC QA Cell Therapy consisting of 4 skilled operational QA professionals. Our main purpose is to safeguard patient safety and ensure product quality and compliance. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, in order to ensure Novo Nordisk’s critical delivery of medicines to patients. 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 Marianne Mørch Hansen +45 3079 8154. Deadline
31st of May. Applications will be screened on an ongoing basis, so you are encouraged 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 Måløv.
Jobbet er oprettet på vores service den 8.5.2023, 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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