Do you have expertise in, and passion for, Quality & Compliance? Would you like to apply your expertise to make an impact in a company that follows the science and turns ideas into life changing medicines, then Clinical Supply Quality might be the one for you! At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Clinical Supply Quality is responsible for compliance decisions that have an impact on AstraZeneca Clinical supplies and therefore AstraZeneca’s business and external reputation. Using risk management to evaluate compliance issues and to develop solutions, decisions are made against a background of regulations. These vary depending on the stage of development and against a set of standards that require interpretation. We have an opportunity for a Quality Advisor, in the Clinical Supply 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 new development drug projects, Good Manufacturing Practice and making sure quality is assured when delivering new products. What you’ll do As a Quality Advisor, you will work with supply chain teams and be responsible for Development Quality release of externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. When working with Clinical Supply functions, the Quality Advisor is 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. Whilst taking on your own specialist areas and making good quality decisions, you will be encouraged to think strategically and to really set the direction. You will participate in lean projects and contribute to continuous improvement. This is a fantastic opportunity to get a good grounding in quality and to broaden your experience in investigational medicinal products and build your career in this field. Operating as part of a global organization with an integrated approach to build an organization with common processes and ways of working you will also provide quality advice and input to: Support the development, implementation and continuous improvement of Good Manufacturing Practice (GMP) quality systems across the functions and support implementation of agreed global standards Support external activities for Packaging, Labelling & Distribution of Investigation Medicinal Product Investigate complaints associated with clinical products Provide quality input into the systems used by the Supply Chain e.g. Smart Supplies In addition, you will provide support and guidance to satisfy external Regulatory Authority GMP inspections, provide appropriate Quality Assurance input to business improvement projects and support Issue Management Teams on specific issues. Essential for the role Degree in pharmacy or similar science or engineering field with at least 3 years' experience working within a pharmaceutical GMP environment A broad and comprehensive understanding of Quality Systems and GMP is essential A comprehensive understanding of the pharmaceutical/drug development process Good communicator with experience of interacting effectively across interfaces Fluent in written and spoken English Desirables for the role Good team working and networking skills, encourages team efficiency Demonstrates independent judgement and uses risk management Capable of making decisions, acting courageously, and communicating with conviction and inspiration Builds good relationships both internally and with external suppliers or service providers Demonstrate a high degree of personal credibility Demonstrate drive and energy in the role to make a difference 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 28th May. 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/ Date Posted 14-maj-2024 Closing Date 28-maj-2024 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.