Quality Advisor
AstraZeneca AB / Biomedicinjobb / Göteborg
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hela Sverige Are you interested in a challenging opportunity within the Development Quality function in one of the world's leading pharmaceutical companies?
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.
We are now looking for three Quality Advisors with GMP focus to strengthen our teams at the Gothenburg site. 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. 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.
What you'll do?
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of internally and externally manufactured Drug Product and Investigational Medicinal Product for clinical trials. You are 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.
The ability to interpret and trend compliance data to measure and improve quality standards is key. 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.
Operating as part of a global organisation with an integrated approach to build an organisation with common processes and ways of working you could also provide quality advice and input to:
• Support the development, implementation and continuous improvement of Good Manufacturing Practice (GMP) quality systems across the functions
• Provide support to external Regulatory Authority GMP inspections
• Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects
• Provide quality advice and approval of documentation related to manufacturing equipment and facilities to ensure compliance, including maintenance, calibration, validation and change control
• Develop quality agreements with suppliers delivering services or products to the pharmaceutical development Supply Chain
Education & Experience Requirements
• MSc in pharmacy or engineering (specializing in Pharmaceuticals) with at least 3 years' experience of working within a pharmaceutical GMP environment
Required Skills
• Broad understanding of Quality Systems and GMP
• Comprehensive understanding of the pharmaceutical/drug development process
• Good communicator with experience of interacting effectively across interfaces
• Fluent in written and spoken English
Desired Skills
• 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 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.
What's next!
If this sounds like the next challenge for you - apply today!
We look forward to your application no later than the June 21, 2020.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2020-05-29ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2020-06-19
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-083032".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5244309
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