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Would you like to work as a QA Specialist in Computerised Systems, in a growing company devoted to make a real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere? If this sounds interesting, 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 are specialized in cardiometabolic diseases (including NAFLD/NASH and chronic kidney disease) and oncology. We have established ourselves as a strategic development partner to the pharmaceutical industry. We combine ground-breaking imaging with profound experience in drug development and deep knowledge of disease mechanisms. Our projects cover clinical trials in all stages of drug development, and we work both with small biotech companies and global big pharma companies. We currently have around 70 employees working at our offices in Mölndal and Uppsala.
As QA Specialist in Computerised Systems , you will provide QA oversight and support the implementation, development and management of compliance related electronic systems in accordance with EU/Annex 11, GAMP and FDA/21 CFR part 11, and Data Integrity GxP requirements (specifically GCP, GLP and GMP).
You will also support the internal departments in developing and maintaining SOPs related to electronic systems as well as work with validation, vendor qualification and compliance. You will be working closely with our QA team; Director IT, COO and Head of Software. The position can be based in either Uppsala or Mölndal.
As QA Specialist in Computerised Systems at Antaros Medical, your main responsibilities will be:
- Provide QA oversight and support the implementation, development and management of computerized systems
- Ensure that the quality system fulfils requirements for validation of computerised systems.
- Advice organization in data integrity and computerised system related questions
- Perform vendor qualification of vendors delivering computerised systems/software
- Take part in internal validation and release of software
- Plan, conduct, and report internal and external audits as detailed in the risk-based audit plan, focusing on computerised systems and data integrity.
- Provide support for CAPAs and system non-conformities for computerised systems.
- Lead and arrange internal trainings in GAMP, validation of computerised systems and data integrity.
Who you are
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 high-quality results and enjoy giving quality related advice to the organisation. You collaborate very well with others and have a team-oriented approach when engaging with colleagues and clients. Last but not least, you value having fun while doing a meaningful job.
- University degree in Natural Science or Medicine.
- Several years experience within the Life Science sector (GxP environment) as an IT Subject Matter Expert or within quality assurance (QA) working with quality of computerised system
- Several years experience from clinical trials from the pharmaceutical-, bio tech- or med tech industry, CROs, or similar business
- Broad understanding of ICH-GCP, EU/Annex 11, GAMP and FDA/21 CFR part 11 and Data Integrity GxP requirements, and other relevant guidelines concerning both operational aspects as well as quality aspects
- Excellent knowledge of spoken and written Swedish and English
For more information about the position, please contact Caroline Engvall, Chief Operating Officer +46 733 319 112.
Please submit your application via this link with a short personal letter in English and your CV included, no later than November 30th, 2020.