Quality Assurance Specialist

at  Qrios Minds AB

Are you interested in a challenging opportunity within the Development Quality function in one of the world’s leading pharmaceutical companies?
The Development Quality function is responsible for quality oversight of the pharmaceutical development activities within AstraZeneca. We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. AstraZeneca’s pharmaceutical development organizations manage all facets of the process of turning a molecule into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase.
We have an exciting opportunity for a 18 months temporary assignment as Quality Advisor, in the Site Quality Gothenburg team, who’ll be the prime source for quality & compliance advice and providing quality support to the science functions and throughout the drug development process chains.
This is a great opportunity for you who are strong in quality and like to work close to development, Good Manufacturing Practice and making sure quality is assured when delivering new products.
About the position
Responsible for quality release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects related to drug product
Providing quality advice and approval of documentation related to equipments, facilities, IT systems and instruments e.g. maintenance, calibration, validation and change control
Providing proactive quality advice to support the development, implementation and continuous improvement of GMP quality systems across the Clinical Supply functions and support implementation of agreed global standards
Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working

Your profile

• Degree in pharmacy or engineering (specializing in Pharmaceuticals)
• 3 years’ experience of working within a pharmaceutical GMP environment
• Broad understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP)
• Fluent in written and spoken English
• Experience of documentation, deviations, changes, and other quality and compliance decisions in the development projects.

As a person, you should have the ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and “can-do” attitude as well as Excellent team working and networking skills and encourages team effectiveness are skills that you possess. We also believe you are a good communicator with experience of interacting effectively across interfaces collaborating internally.
About the organisation
This is a consultant assignement for 12 months at AstraZeneca Göteborg. During this time you will be hired by QRIOS.

Please refer the Job description for details