Senior QA Professional
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Måløv
Senior QP delegate with CMO expertise Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, we have an exciting possibility waiting for you as Senior QA Professional and QP delegate in CMC PPF QA! As part of Novo Nordisk’s R&D family, CMC Development makes a difference for patients with chronic diseases across the world and the organisation develop, manufacture and distribute drug candidates for non-clinical and clinical trials. CMC Development and CMC QA is an ambitious organisation with a strong culture, that always seek to solve problems, have an eye for the entire business and do our best to deliver despite any obstacles along the way. We have a high focus on delivering high quality to our customers which is why we are looking for a QA Professional to take an active part in securing our quality level.
The job
As a Senior QP delegate, you will be responsible for delivering best-in-class quality assurance of our new manufacturing processes and drug product for clinical trials. In your daily work you will challenge and approve documents in connection with development, manufacture, stability and status assignment of clinical batches produced in CMC and PS. In addition, you will be a part of our development projects ensuring our products used in clinical trials are following the information provided to Health Authorities worldwide. 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. You will primarily be working in Måløv and must expect several traveling days as we are outsourcing more and more of our clinical batch productions to different international Contract Manufacturing Organisations (CMO). You will participate in pre-assessments of new CMO´s, act as Subject Matter Expert at audits, occasionally conduct quality oversight and review batches at the CMOs.
Qualifications
You hold a MSc in Pharmacy, Engineering, Biology, Chemistry or similar. You have 7+ years of experience with GMP and quality assurance - preferably within batch release/status assignment. Experience with qualification activities in (aseptic) production is a great advantage. The idea candidate has been working with outsourcing/CMO collaboration and brings solid knowledge into the position. The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders – internally and externally. You have very good communication as well as collaboration skills and must speak and write English fluently. We also expect that you speak, read and understand Danish at a high professional level.
About the department You will become part of a department consisting of three teams where we currently are more than 20 dedicated colleagues and several open positions as we are expanding. 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 13th of February 2023 Applications will be screened on an ongoing basis, and we will hire as soon as the right candidate is in place. Hence, we encourage you to apply today. 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.
The job
As a Senior QP delegate, you will be responsible for delivering best-in-class quality assurance of our new manufacturing processes and drug product for clinical trials. In your daily work you will challenge and approve documents in connection with development, manufacture, stability and status assignment of clinical batches produced in CMC and PS. In addition, you will be a part of our development projects ensuring our products used in clinical trials are following the information provided to Health Authorities worldwide. 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. You will primarily be working in Måløv and must expect several traveling days as we are outsourcing more and more of our clinical batch productions to different international Contract Manufacturing Organisations (CMO). You will participate in pre-assessments of new CMO´s, act as Subject Matter Expert at audits, occasionally conduct quality oversight and review batches at the CMOs.
Qualifications
You hold a MSc in Pharmacy, Engineering, Biology, Chemistry or similar. You have 7+ years of experience with GMP and quality assurance - preferably within batch release/status assignment. Experience with qualification activities in (aseptic) production is a great advantage. The idea candidate has been working with outsourcing/CMO collaboration and brings solid knowledge into the position. The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders – internally and externally. You have very good communication as well as collaboration skills and must speak and write English fluently. We also expect that you speak, read and understand Danish at a high professional level.
About the department You will become part of a department consisting of three teams where we currently are more than 20 dedicated colleagues and several open positions as we are expanding. 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 13th of February 2023 Applications will be screened on an ongoing basis, and we will hire as soon as the right candidate is in place. Hence, we encourage you to apply today. 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 17.1.2023, 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.
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