QA Professional
Bagsværd
x 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 QA Professional 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. The position We are seeking a highly motivated and experienced Quality Assurance Professional to join our CMC API QA team. The successful candidate will support CMC API Development within the raw material and CMO shipping area. You will be responsible for ensuring compliance with regulatory requirements, quality standards, and company policies. Key responsibilities:
• Responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials.
• Challenge and approve documents in connection with raw materials and CMO shipping.
• Responsible for securing quality agreements with external suppliers.
• Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements. You will be a part of our development projects ensuring that raw materials to 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 if needed and act as a consultant for stakeholders. You will contribute to finding solutions for ad hoc questions, deviations, and challenges within cGMP compliance. 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. We make a difference in the lives of people participating in clinical trials in A/S◀, by ensuring that the products they receive are safe, of the highest quality, and produced in compliance with legislation. Qualifications
We seek a colleague who fits our team both professionally and personally. • You hold a MSc in Engineering, Biology, Chemistry or similar.
• You have experience with GMP and quality assurance and have experience working with raw materials for API production.
• You have experience with status assignment combined with understanding of how the pharmaceutical industry works.
• Proficiency in both English and Danish is mandatory.
Soft skills
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 with a necessary and sufficient mindset, make decisions and follow-up on quality related problems. 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.
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 clinical trials. We also have the responsibility of releasing API from contract manufacturers across the globe. In the department, we value teamwork, diversity and humour very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor. Contact For further information, please contact QA Manager Michael Ellebæk Kongsgaard at +. Deadline
June 6, 2024.
Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline.
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.
• Responsible for delivering best-in-class quality assurance of raw materials and CMO shipping area to our drug substance and drug product production for clinical trials.
• Challenge and approve documents in connection with raw materials and CMO shipping.
• Responsible for securing quality agreements with external suppliers.
• Participate in regulatory inspections and audits and ensure compliance with cGMP and other regulatory requirements. You will be a part of our development projects ensuring that raw materials to 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 if needed and act as a consultant for stakeholders. You will contribute to finding solutions for ad hoc questions, deviations, and challenges within cGMP compliance. 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. We make a difference in the lives of people participating in clinical trials in A/S◀, by ensuring that the products they receive are safe, of the highest quality, and produced in compliance with legislation. Qualifications
We seek a colleague who fits our team both professionally and personally. • You hold a MSc in Engineering, Biology, Chemistry or similar.
• You have experience with GMP and quality assurance and have experience working with raw materials for API production.
• You have experience with status assignment combined with understanding of how the pharmaceutical industry works.
• Proficiency in both English and Danish is mandatory.
Soft skills
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 with a necessary and sufficient mindset, make decisions and follow-up on quality related problems. 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.
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 clinical trials. We also have the responsibility of releasing API from contract manufacturers across the globe. In the department, we value teamwork, diversity and humour very high, and we will make sure you, as a new employee, feel welcome and integrated. Further, a thorough individual training plan will be made together with your mentor. Contact For further information, please contact QA Manager Michael Ellebæk Kongsgaard at +. Deadline
June 6, 2024.
Applications will be evaluated continuously when received, and candidates may be called for interview before the deadline.
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.
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Arbejdsstedet er beliggende i Bagsværd.
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