QA Specialist to Antaros Medical

How does working as a QA Specialist in a growing company devoted to making a real difference in drug development through ground-breaking imaging, sound to you? Do you get energy from working in a dynamic environment where you quickly can apply your competence and have a clear impact in your work? How about a place that is constantly moving forward, with great science, great people, and an informal atmosphere? If this catches your interest, you should continue reading.

At Antaros Medical, we are pioneering imaging methodologies, such as Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET), to design and deliver clinical studies for decision making and differentiation in drug development.

We value competence and development as well as ideas and solutions. Relations and trust are keys to success, and it is equally important for us to have fun while doing a meaningful job. We have currently around 120 employees working at our offices in Sweden in Gothenburg, Uppsala and Malmö, as well as a newly established subsidiary in the US, and we are continuously growing and developing.

To deliver on our commitments, we are now looking for a QA Specialist with experience in clinical drug development and GCP to join us. The position is ideally based in our Uppsala, Mölndal or Malmö office in Sweden but could possibly be placed home-based in Sweden as well, in which case regular travel to our Uppsala or Mölndal office would be expected.

What would you be responsible for as a QA Specialist at Antaros Medical?

As a QA Specialist, you will be working with, and take operationally responsibility for, a large scope of various QA activities and processes within Antaros Medical, including support with improvement and development initiatives within QA.

Your main responsibilities:

- Support the development of new SOPs, templates, and other quality system documents
- Conduct and work with the implementation of internal and external audits
- Host and manage inspections, Sponsor audits, and desk-top audits until closure
- Assist with information in RFIs/vendor assessments
- Work with complaints, deviations and CAPA workflows
- Perform vendor qualification activities
- Provide day to day general QA support internally
- Be up to date with all regulations relevant to our business and inform the organisation of updates


Who are we looking for?

We believe that you are a structured and communicative person who will thrive in our dynamic and rapidly developing environment. You are focused on delivering thorough and high-quality results and enjoy giving quality-related advice to the organisation. You have further a lens for improvement possibilities where initiatives based on your competence and knowledge falls naturally for you in your performance.

You collaborate very well with others, by being attentive and having a team-oriented approach when engaging with colleagues and clients. Last but not least, you value having fun while doing a meaningful job.

Requirements:

- University degree in Natural Science, Medicine or similar field.
- QA-experience in the pharmaceutical industry
- Experience from working with clinical trials
- Understanding of ICH-GCP and other relevant guidelines
- Excellent knowledge of spoken and written Swedish and English


Knowledge within imaging in clinical trials is perceived as an advantage for the role however not required, as well is knowledge in GLP, GMP and/or GDP.

Are you interested?

Wonderful to hear! Please submit your application via the link with a short personal letter (in English) and your CV included, no later than November 27th, 2022.

Please attach degree certificates from higher level education(s) together with your application.

For more information about the position, please contact Johannes Carlsson, VP IT & QA, on +46(0)73-917 86 50, or johannes.carlsson@antarosmedical.com

We only accept applications via our recruitment system, Teamtailor. The recruitment is handled by Antaros Medical. We kindly decline any contact from recruitment- or staffing firms.

About Antaros Medical

At Antaros Medical, we combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. We are specialised in cardiorenal & metabolic diseases and oncology. We have a global network of collaboration partners and customers, including both Big Pharma and Biotechs, and several European collaboration initiatives such as Innovative Medicines Initiative (IMI) and COST.

Antaros Medical has delivered small complex, mechanistic studies as well as multi-center clinical trials worldwide utilizing our innovative imaging methods. Our global headquarter and imaging Corelab are based in Sweden, and we have recently opened a subsidiary in the US.

You are very welcomed to visit our website to learn more about our company: www.antarosmedical.com (http://www.antarosmedical.com)

Our culture is our people, and our values make us everything that we are. Please feel free to have a look upon our Culture Handbook to get to know us even more: Our people - Antaros Medical (https://antarosmedical.com/our-people/)