Quality Assurance Advisor

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

The arena
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 in 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.


About the position
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are expected to assure that activities and processes across the development chain are delivered to appropriate standards to meet regulatory expectations and assure product integrity and acceptability.

You will develop and maintain a knowledge of the quality regulations and guidelines applicable to your area and a deep scientific understanding of the products that you are supporting. In your role you will have interactions with internal and external stakeholders.

Responsibilities
Typical Accountabilities:
• Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials
• Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities
• 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
• Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects
• Provide appropriate Quality Assurance input to business improvement projects
• Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.

Your profile
Minimum requirements – Education and Experience
• MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 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)
• Comprehensive understanding of the pharmaceutical/drug development process
• Good communicator with experience of interacting effectively across interfaces
• Understanding of Project Management processes
• Fluent in written and spoken English

Preferred requirements
• Experience preferably within a pharmaceutical manufacturing organization
• Good team working and networking skills
• Capable of making effective decisions
• Demonstrate drive and energy in the role to make a difference
• Demonstrate a high degree of personal credibility

About the organisation
This position is a consultant assignment at AstraZeneca via QRIOS Life Science & Engineering in Göteborg for one year. During this time you will be employed by QRIOS Life Science & Engineering.
QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we are opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.