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.

Om tjänsten

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.


Dina arbetsuppgifter i huvudsak

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.


Vem är du?

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.


Om verksamheten

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status or any other characteristic protected by law.

This is a consulting assignment at AstraZeneca and during the period you will be employed by Poolia.

Preferred start date 2020-11-15.
End date: 2021-11-12 and with possibilities of extension.

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