AstraZeneca seeking a Quality Assurance specialist

We are currently seeking a motivated Quality Assurance specialists to join AstraZeneca in Gothenburg.

Are you open to a new opportunity within the Development Quality function of one of the world’s leading pharmaceutical companies? We are currently looking for a Quality Assurance specialists with a GMP focus to join the Gothenburg team at AstraZeneca!

The Quality Advisor role involves ensuring that all requirements, both internal and external, are met for AstraZeneca´s projects in the development phase.

Purpose, Offer and Benefits

This is a 1-year consulting assignment starting in June. You will be employed by TNG during the duration of the assignment. Please note that the selection process is ongoing.

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.

Your Responsibilities

• 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

The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. In the role 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.

Our Expectations

• 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.

Desirable:

• Experience within a pharmaceutical manufacturing organization.
• Understanding of Project Management processes.