QA Principal Scientist

The position

As a QA Principal Scientist, you will be responsible for ensuring the right and balanced compliance level in API (QC) laboratories by being consulted in all complicated cases related to compliance. You will be setting scientific direction within QA for QC & MDEV and together with the management team develop the organization and developing the team scientifically. You will be a member of the management team in the department API QA Operational and Business Support. Your key responsibilities will include: Serving as a QA specialist and partner for API QC and MDEV. Taking responsibility and participate as QA for API in the Novo Nordisk Focus Groups and related to QC and MDEV. Acting as a sparring partner for stakeholders when it comes to QA for new groundbreaking technologies, providing technical expertise and guidance on quality-related issues. Handling analytical transfer of methods as well as qualification of apparatus and validation of methods and setting the standards. Moreover, you will be a main actor in fulfilling the QC strategies and being QA responsible in future strategic initiatives in the laboratories. You will continuously participate in other cross-functional activities to support the development and optimization of manufacturing processes and the implementation of new technologies and analytical methods to improve product quality and efficiency. We take pride in assuring that you always have challenging and impactful working assignments to ensure continuous development and realization of your full potential. Equally important, we have a high focus on a great work-life balance, with the flexibility to work from the office and home. Qualifications We are looking for an experienced colleague with a strong experience from QC and/or MDEV and process development within relevant technologies. You are bold and know how to balance quality demands, authority expectations, and business needs.To succeed in this role, you have: Master's degree in natural sciences or a related field, and years of experience in Quality Control and manufacturing in the pharmaceutical industry. Solid experience in API (Active Pharmaceutical Ingredient) manufacturing and development. Strong knowledge of QC methods, processes and regulations. In depth knowledge about automation flow in QC. Competencies within PAT (Process Analytical Technology) techniques. In addition, you have process development experience within integrated methods, which involves the development and optimization of integrated manufacturing processes that incorporate multiple unit operations and analytical techniques to improve efficiency and product quality. You are experienced in managing working groups and teaching at all levels. You possess excellent communication and collaboration skills, are fluent in English, and can work both independently and as part of a team.As a person you are flexible and have a talent for identifying possibilities to work better and smarter, as well as solving complex problems. You are convincing and have a great deal of clout when communicating GMP requirements, ensuring that quality standards are met throughout the process. You are committed to ensuring that goals are fulfilled according to plans, with a strong focus on delivering results and meeting deadlines. About the department In our department API QA Operational and Business Support we are 42 highly dedicated employees, mostly specialized academics, divided into 2 teams. The API QA Operational Support team is the QA function for QC and Mandev, furthermore they are QA for API business support functions (example: metrology, technical warehouse) and we are QA for a corporate function in Novo Nordisk Quality, Quality systems. Besides the API QA Operational Support team, the department also consists of a Business Support team. In our department we focus on maintaining a social work environment where there is a high level of engagement, focus on development while also having fun. We love professional challenges, and we take pride in delivering on our commitments. 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 are anchored on scientific innovation through the power of our diverse differences. We embrace the spirit of experimentation and strive 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 are all working together to advance patient care.

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