Senior QP delegate in CMC API QA
8 hours ago
Jobbeskrivelse
Placering
Bagsværd, Denmark
Jobkategori
Quality
Ansøg nu
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 and thereby secure and support the development pipeline in Novo Nordisk? If so, we have an exciting possibility waiting for you as Senior QP delegate in Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredients (API) QA. Read more and apply now
We offer you a unique position with a lot of impact in a dynamic environment and an opportunity to really develop your skills professionally and personally. For an introduction to the area we support - CMC API Pilots - please visit our career page.
The position
We are seeking a highly motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The successful candidate will serve as QP delegate, primarily responsible for releasing internal and externally produced API for usage in the Novo Nordisk clinical trial pipeline. You will also be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies in the manufacturing of APIs.
Your key responsibilities will include:
• Ensuring best-in-class quality assurance of our API for clinical trials in phase I, II and III testing.
• Challenge and approve documents related to the development, manufacture, stability, and status assignment of internal and external produced API.
• Ensuring that our products used in clinical trials are following the information provided to Health Authorities worldwide.
• Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements.
In our department, we are continuously improving the quality of work, and we are constantly optimising our methods and processes to increase simplicity across CMC QA and CMC Development & Scaling. Join us in making a difference in the lives of people participating in clinical trials, by ensuring safe and high-quality products, manufactured in compliance with legislation.
Qualifications
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.
To succeed in this role, you should:
• Hold a Master in Pharmacy, Engineering, Biology, Chemistry or similar to fulfil the requirements to become a “Qualified Person” (QP), according to The Danish Medicines Agency certification.
• Have extensive experience in a pharmaceutical company, ideally also in a QA role.
• Possess a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production, and hence can navigate without adding complexity.
• Be proficient in English and Danish.
• Proficiency in SAP and/or PasX along with experience with API and CMOs, will be seen as an advantage.
On a personal level, 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 top of the agenda, and you like working with many different stakeholders – internally and externally.
About the department
CMC API QA is a department which employ 35 skilled and motivated colleagues in four teams, all based in Bagsværd. We work with assuring quality and compliance of the CMC API facilities, equipment, quality management system, materials as well as the release of API for all clinical trials within Novo Nordisk. We also have the responsibility of releasing API from contract manufacturers across the globe. You will be part of the Product & Celle Bank team consisting of both QP delegates, QA professionals and QA assistants.
Our team’s culture ensures a healthy and fun working environment where we value strong relationships, people growth and optimisation of our processes. Our main purpose is to safeguard patient safety and ensure product quality and compliance in the CMC area, and ultimately release API 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 Manager Michael Kongsgaard +45 3448 2627.
Deadline
31 July 2024.
Please note that interviews will be scheduled as soon as relevant candidates are identified, so we encourage you to apply sooner rather than later.
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.
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