Quality Assurance Advisor at AstraZeneca

Interested in a challenging opportunity within the Development Quality function? AstraZeneca is looking for a Quality Advisor!

We are now looking for a Quality Assurance Advisor with GMP focus to the Gothenburg team at AstraZeneca. As a Quality Assurance Advisor you will have a broad range of responsibilities to ensure all internal and external requirements are fulfilled for the AstraZeneca projects in the development phase. The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. Does this sound like a job for you? Don´t hesitate to submit your application!

Purpose, Offer and Benefits

At AstraZeneca, we have a unique workplace culture that inspires innovation and collaboration. Here, you are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for your ideas and creativity.

As a Quality Advisor you will have the opportunity to 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 will 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.

Your 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.

The Bigger Picture

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. AstraZeneca´s drug development organizations manage all aspects of the process of turning a molecule into a drug that can be safely and effectively used by patients.

This position is a full-time job of a 1 year long consulting assignment at AstraZeneca, which means that you will be employed by TNG during this time.

Our Expectations

Essential for this role:

• Degree in pharmacy or engineering (specializing in Pharmaceuticals) with at least few 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