QA Senior Validation professional in CMC OP Dev QA
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Måløv
Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Would you like to be part of an exciting growth journey within development of our oral portfolio with cross functional stakeholders and close teamwork? If so, we have an exciting possibility waiting for you as QA senior Validation professional in CMC OP Dev (Oral Product Development). The position
You will be responsible for delivering best-in-class quality for qualification of facilities and equipment according to science and risk-based validation (SRV) principles. You will challenge and approve documentation, conduct QA oversight, and participate in project workshops prior to setting and approving criteria for new facilities and equipment’s. As we support the oral development department you should expect to work with new kinds of equipment and processes. Furthermore, you will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities’ compliance level and act as a consultant for them. The position is based in Måløv, Denmark. Office presence expected at minimum three days weekly.
Qualifications You hold a MSc in Engineering, Chemistry, Pharmacy or similar. You have 5+ years of experience within GMP and quality assurance. You have experience working with qualification of facilities and equipment. You understand the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. You are self-driven and independent person, with a high sense of responsibility and initiative. You thrive in a dynamic environment, where teamwork is on the top of agenda. You like working with many different stakeholders. As we operate both in a national and an international environment, you must speak and write Danish and English fluently. The ideal candidate has experience with the SRV concept in Novo Nordisk. Further, Novo Nordisk and CMC is on a digitalization journey and experience working with IT validation will be an advantage as it will be possible to combine these skills in the job.
About the department You will become part of a department (CMC OP Dev QA & Analysis QA) consisting of two teams where we currently are 25 dedicated colleagues. You will be part of the CMC OP Dev QA team, reporting directly to the QA director. You will be part of a strong culture, where we strive for high psychological safety, give regular feedback, and understand that the most important thing we have is our people. Our main purpose is to safeguard patient safety and ensure product quality and compliance in the CMC area, and ultimately release drug candidates for clinical trials. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, to ensure Novo Nordisk’s critical delivery of medicine 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 QA Director Casper Yding +45 3079 7015 Deadline 20.06.2023 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. 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.
You will be responsible for delivering best-in-class quality for qualification of facilities and equipment according to science and risk-based validation (SRV) principles. You will challenge and approve documentation, conduct QA oversight, and participate in project workshops prior to setting and approving criteria for new facilities and equipment’s. As we support the oral development department you should expect to work with new kinds of equipment and processes. Furthermore, you will - in close cooperation with your colleagues - identify and contribute to strengthening our production facilities’ compliance level and act as a consultant for them. The position is based in Måløv, Denmark. Office presence expected at minimum three days weekly.
Qualifications
About the department You will become part of a department (CMC OP Dev QA & Analysis QA) consisting of two teams where we currently are 25 dedicated colleagues. You will be part of the CMC OP Dev QA team, reporting directly to the QA director. You will be part of a strong culture, where we strive for high psychological safety, give regular feedback, and understand that the most important thing we have is our people. Our main purpose is to safeguard patient safety and ensure product quality and compliance in the CMC area, and ultimately release drug candidates for clinical trials. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, to ensure Novo Nordisk’s critical delivery of medicine 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 QA Director Casper Yding +45 3079 7015 Deadline 20.06.2023 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. 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 5.5.2023, 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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