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 QA ADVICE INTO MANUFACTURING ACTIVITIES OF DRUG PRODUCT AND PATIENT MEDICATION
• PERFORM QA RELEASE OF MANUFACTURED AND PACKED DRUG PRODUCT AS PART OF THE SUPPLY CHAIN TO CLINICAL TRIALS
• SUPPORT THE PHARMACEUTICAL DEVELOPMENT FUNCTIONS WITH INVESTIGATIONS OF DEVIATIONS, COMPLAINTS, CHANGES AND OTHER QUALITY AND COMPLIANCE DECISIONS IN THE DEVELOPMENT PROJECTS
• PROVIDE APPROPRIATE QA INPUT TO BUSINESS IMPROVEMENT PROJECTS
• COLLABORATION WITH ASTRAZENECA QA COLLEAGUES GLOBALLY
• RESPONSIBLE FOR QA ADVICE AND APPROVAL OF DOCUMENTATION RELATED TO MANUFACTURING EQUIPMENT AND FACILITIES TO ENSURE COMPLIANCE, INCLUDING MAINTENANCE, CALIBRATION, VALIDATION

THE ROLE MAY ALSO INCLUDE
• INTERPRET, TREND AND REPORT COMPLIANCE DATA, TO MEASURE AND IMPROVE QUALITY STANDARDS WITHIN THE PHARMACEUTICAL DEVELOPMENT FUNCTIONS.
• DEVELOP QA AGREEMENTS WITH INTERNAL SUPPLIERS DELIVERING SERVICES OR PRODUCTS.

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
• FLUENT IN WRITTEN AND SPOKEN ENGLISH

PREFERRED REQUIREMENTS
• EXPERIENCE PREFERABLY WITHIN A PHARMACEUTICAL MANUFACTURING ORGANIZATION
• GOOD TEAM WORKING AND NETWORKING SKILLS
• CAPABLE OF MAKING EFFECTIVE DECISIONS
• DEMONSTRATE A HIGH DEGREE OF PERSONAL CREDIBILITY

ABOUT ALTEN
ALTEN is a consulting company that develops and delivers expertise for world-leading companies with consultants in technology, IT and biochemistry. We are located in over 28 countries, have our headquarter in Paris and have more than 37 200 employees, of which 88 percent are engineers. In Sweden, we have over 1 700 employees and work from offices in twelve locations. Our clients are found in industries such as Automotive, Energy, Telecom, Industry, Aerospace & Defence and Life Science, where our consultants operate throughout the product development chain.

Welcome to read more about us at alten.se or please contact Oscar Sundell, Business Manager at Oscar.Sundell@alten.se.