AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers 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 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 12 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

The role
Working in the Site Quality team means you will work closely with the internal assets/facilities, teaming up with the pharmaceutical development functions and be involved in cross business processes. To build strong relationships with these functions knowing their business is key, to give support to projects and develop ways of working that builds for success.

The ability to interpret and trend compliance data to measure and improve quality standards is key. 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.

Whilst taking on your own specialist areas and making good quality decisions, you will be encouraged to think strategically and use your problem solving skills to resolve any quality issues. You will participate and contribute to continuous improvement projects with the aim to standardize and simplify our internal processes.

Typical Accountabilities:
• 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 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

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
• Demonstrates understanding of international quality systems regulations, concepts, industry practices to adopt best in class processes
• A comprehensive understanding of GMP regulations, the pharmaceutical development process and supply chain process would be advantageous
• Experience of interacting effectively across interfaces collaborating internally in a good communicative way
• Fluent in written and spoken English

Required soft skills:
• Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and “can-do” attitude
• Excellent team working and networking skills and encourages team effectiveness
• A good communicator with experience of interacting effectively across interfaces collaborating internally

About AstraZeneca Gothenburg Hub
Our stunning campus in Gothenburg is one of AstraZeneca’s three strategic science centers. The site is home to over 2,500 employees, from 50 different nationalities. Gothenburg includes the complete range of functions, and as such offers plenty of development opportunities for a wide range of professionals. Our science teams in Gothenburg collaborate with academic and industry partners in Sweden and globally. And the site itself has been designed with collaboration in mind. From the Coffee Lab to exercise areas, we’ve built a series of environments where innovation can happen.

This is a consultancy assignment at AstraZeneca, and during the assignment, you will be employed by Logent.