Quality Assurance Advisor, AstraZeneca Gothenburg

Job description
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.

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 deal with 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. You will also have the possibility to contribute with expert advice to the pharmaceutical development functions and to the delivery of our pipeline of exciting new medicines. This is a consulting assignment at AstraZeneca in Gothenburg.

Responsibilities
In your role you will have interactions with internal and external stakeholders.
Provide 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.
Provide Dev Q input into support of external activities for Packaging, Labelling & Distribution of IMP as required.
Provide quality input into the set-up and execution of IRT for clinical studies
Provide quality input into complaints associated with clinical products.
Provide quality input into the systems used by the Supply Chain e.g. Smart Supplies
Responsible for Dev Q release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials
Provide appropriate Quality Assurance input to business improvement projects.
Operate as part of a global organization with an integrated mindset to create an organization with common processes and ways of working.


Qualifications
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 the Pharmaceutical Quality Systems, 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 and encourages team effectiveness
Capable of making effective decisions
Demonstrate drive and energy in the role to make a difference
Demonstrate a high degree of personal credibility

For us, it is important that all competence and skills in the labor market are utilized. We welcome all applicants and strive for diversity.

Application
2021-03-23, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information, please contact Linnea Öster linnea.oster@randstad.se

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Randstad Life Sciences is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!