Are you eager to join a fast-growing scientifically-driven CRO company? Now you have a unique opportunity as we are looking for a Quality Assurance Professional who shares our passion, drive, and energy for research within oncology and cardiovascular diseases and in vivo molecular imaging for translational research and drug development.
Minerva Imaging is a fast-growing and entrepreneurial-driven CRO with the ambition to be the globally leading CRO in our area of expertise. We aim to excel in delivering customized cancer radiopharmaceutical research and serve as an extended research team for our collaborators. We are currently building a new sterile production facility, and to facilitate the outbuild of our pharmaceutical quality system (PQS) and strengthen the support of our project validation team, we seek a dedicated and talented scientist to join and strengthen our Quality Assurance unit as a QA Professional.
The ideal candidate has a strong scientific understanding, preferably within the analytical chemistry area combined with a high level of academic writing skills. Your interest in quality assurance and your dedication to delivering high-quality work is more important than many years of industry experience. Mindset-wise you must be a citizen of the new digital era.
As an individual you are detail-oriented, thorough, reflective, work structured with a persistent attitude and a critical thinking mindset to deliver high-quality work, and you are a relaxed, kind, and helpful colleague.Your tasks are varied (and shared within the QA unit) but include
- Build and upgrade our ePQS (electronic quality management system). Our ePQS covers our research and development studies, GLP archive, and GMP activities.
- Work as an ePQS superuser and trainer (we will train you in our ePQS) and process responsible for CAPAs, non-conformities, and change control processes.
- Support colleagues with the drafting of SOPs, work instructions, forms, etc. meaning that you help your colleagues from start to end in their drafting process (medical writing), making sure that all our procedures are consistent across our ePQS and of high quality.
- GMP QA tasks e.g., review of data packages and certificates of analysis, review of qualification/validation documents and review of SOPs, work instructions, non-conformities, change requests, CAPAs, etc.
On a personal note, you are
- A natural sciences background at MSc level or higher e.g., as a pharmacist, engineer, or chemist is required. Experience in radiochemistry or analytical chemistry is considered an advantage.
- A strong interest in pharmaceutical quality assurance is required.
- Experience with sterile production, analytical method development, validation/qualification, and/or quality assurance is considered an advantage. Likewise, recent professional GMP courses are also considered an advantage.
- Strong skills and experience with Excel are preferable.
- Data-oriented mindset, strong skills within applied IT, and critical thinking is required.
- Strong academic writing skills in English.
- Fluent communication and presenting skills in English and Danish are required.
- Experience with cross-functional teams and an ability to bridge across disciplines are preferable and will be part of your role.
- Relaxed, kind, and polite.
- Thorough and detail-oriented.
- Strong critical thinking skills.
- Work independently on agreed tasks with a solution-oriented attitude.
- Work structured towards meeting deadlines.
- Thrive in a fast-paced and dynamic service organization with an extremely high academic level.
We are an informal organization with a strong focus on open and honest communication. We value humor and a natural care for one another, meaning stepping up and lending a helping hand to a colleague when needed.
Sounds like you, please submit your application no later than August 7th, 2022, by applying using the link. The application must include a motivated cover letter and a CV addressing the listed qualifications.
If you have questions regarding the recruiting process, please contact Talents2work; Janne Erwolter at +45 4023 6033 or at email@example.com
Applications will be evaluated continuously, and potential candidates will be invited for job interviews accordingly.About Minerva Imaging
Minerva Imaging is a scientifically-driven CRO founded in 2011 approaching 80 employees. Our focus is on the use of advanced animal models within oncology and cardiovascular diseases and in vivo molecular imaging for translational research and drug development. We engage with our collaborators to understand their scientific questions and discuss how our methods and capabilities can provide answers. We are rapidly growing, and the right candidate will be a key contributor to maintaining the scientific foundation and our approach to research while expanding our business. You will join a highly specialized CRO, with ambitions of taking disease treatment to the next generation of personalized medicines.