Senior QP delegate in CMC API QA
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Bagsværd
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 ? 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 motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The candidate will serve as QP delegate and be responsible for releasing internal and externally produced API for usage in the 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 and cGMP. Participate in regulatory inspections and audits. 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 some years of experience in a pharmaceutical company, also in a QA role. Possess a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production. Be proficient in English and Danish. If you have been working API and CMOs, and/or have knowledge in SAP and/or PasX, it with 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 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 . We also have the responsibility of releasing API from contract manufacturers across the globe. You will be part of the Product & Cell 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 Quality, we support the business and strive for simplicity every single day, to ensure ’s critical delivery of medicine to patients. Working at
At , 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 +.
Deadline 10 September 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 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.
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 motivated and experienced Senior Quality Assurance Professional to join our CMC API QA team. The candidate will serve as QP delegate and be responsible for releasing internal and externally produced API for usage in the 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:
On a personal level, you are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your 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 . We also have the responsibility of releasing API from contract manufacturers across the globe. You will be part of the Product & Cell 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 Quality, we support the business and strive for simplicity every single day, to ensure ’s critical delivery of medicine to patients. Working at
At , 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 +.
Deadline 10 September 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 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 Bagsværd.
Jobbet er oprettet på vores service den 16.5.2024, 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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