Quality Advisor, Development Quality

Are you interested in a challenging opportunity within the Development Quality function? AstraZeneca is seeking a Quality Advisor!

We have an exciting opportunity for a Quality Advisor role at Astrazeneca in the Site Quality Gothenburg team. You will 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.

Purpose, Offer and Benefits

This is a 12-month consulting assignment starting immediately. You will be employed by TNG during this time.

At AstraZeneca, we´re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There´s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

Your Responsibilities

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 quality advice and approval of documentation related to equipments, facilities, IT systems and instruments e.g. maintenance, calibration, validation and change control
• 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

The Bigger Picture

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

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.

Please note that the selection process is ongoing!

Our Expectations

• 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
• 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
• Fluent in written and spoken English