Quality Assurance Advisor

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. 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. 

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 in AstraZeneca. We are now looking for a Quality Advisor with GMP focus to our Gothenburg team. AstraZeneca’s pharmaceutical development organizations deal with 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. You will also have the possibility to contribute with expert advice to the pharmaceutical development functions and to the delivery of our pipeline of exciting new medicines.


THE ROLE
IN YOUR ROLE YOU WILL HAVE INTERACTIONS WITH INTERNAL AND EXTERNAL STAKEHOLDERS.
•PROVIDE 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.
•PROVIDE DEV Q INPUT INTO SUPPORT OF EXTERNAL ACTIVITIES FOR PACKAGING, LABELLING &AMP DISTRIBUTION OF IMP AS REQUIRED.
•PROVIDE QUALITY INPUT INTO THE SET-UP AND EXECUTION OF IRT FOR CLINICAL STUDIES
•PROVIDE QUALITY INPUT INTO COMPLAINTS ASSOCIATED WITH CLINICAL PRODUCTS.
•PROVIDE QUALITY INPUT INTO THE SYSTEMS USED BY THE SUPPLY CHAIN E.G. SMART SUPPLIES
•RESPONSIBLE FOR DEV Q RELEASE OF EXTERNALLY MANUFACTURED DRUG PRODUCT AND INVESTIGATIONAL MEDICINAL PRODUCT FOR CLINICAL TRIALS
•PROVIDE APPROPRIATE QUALITY ASSURANCE INPUT TO BUSINESS IMPROVEMENT PROJECTS.
•OPERATE AS PART OF A GLOBAL ORGANIZATION WITH AN INTEGRATED MINDSET TO CREATE AN ORGANIZATION 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
• BROAD UNDERSTANDING OF THE PHARMACEUTICAL QUALITY SYSTEMS, GMP AND RELATED ACTIVITIES TO INVESTIGATIONAL MEDICINAL PRODUCT (IMP)
• COMPREHENSIVE UNDERSTANDING OF THE PHARMACEUTICAL/DRUG DEVELOPMENT PROCESS
• GOOD COMMUNICATOR WITH EXPERIENCE OF INTERACTING EFFECTIVELY ACROSS INTERFACES
•UNDERSTANDING OF PROJECT MANAGEMENT PROCESSES
• FLUENT IN WRITTEN AND SPOKEN ENGLISH

PREFERRED REQUIREMENTS
• Experience preferably within a pharmaceutical manufacturing organization
• Good team working and networking skills and encourages team effectiveness
• Capable of making effective decisions
Demonstrate drive and energy in the role to make a difference
• Demonstrate a high degree of personal credibility