Quality Advisor – Development Quality

Are you interested in a thrilling opportunity within the Development Quality function in one of the world’s leading pharmaceutical companies?

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 Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. We have an exciting opportunity as a 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. 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. 

This is a great chance for you who are strong in quality and like working close to development, Good Manufacturing Practice and making sure quality is assured when delivering new products! 

What you’ll do

Working in the our team means you will be working closely with the internal assets/facilities, teaming up with the development functions and being involved in cross business processes. Key for you is to build strong relationships with these functions, get to know their business, to be able to give support to projects and develop ways of working. 

The role interprets and trend compliance data to measure and improve quality standards. 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. You will take on specialist areas, make good quality decisions and 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: 

• Accountable for quality release of manufactured Drug Product, Investigational Medicinal Product for clinical trials  
• 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  
• Support 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 attitude to create an organisation with common processes

Essentials for the role

• 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, diligent, 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

In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. We balance the expectation of being in the office while respecting individual flexibility.

Are you already imagining yourself joining our team – good, because we can’t wait to hear from you!

Welcome with your application no later than 11th June, 2023. Curious to know more, contact Vesna Gaborit (vesna.gaborit(at)astrazeneca.com) for more information.

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.

Where can I find out more:

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Our Gothenburg site: https://www.astrazeneca.com/our-science/gothenburg.html

Life in Gothenburg: https://www.movetogothenburg.com/

Culture and atmosphere of the Gothenburg site: https://www.linkedin.com/feed/update/urn:li:activity:6496327311678410752/

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.