Quality Assurance Specialist

Do you have broad understanding of GMP and Pharmaceutical Quality Systems? Are you a strong communicator with interest in the pharmaceutical industry? We are now looking for a Quality Assurance Specialist to join Poolia Life Science for a consultant assignment at Astra Zeneca. Poolia Life Science is a leading recruitment and consultant company providing a platform, where you will have the opportunity to interact with a broad network of Life Science specialists. We value your knowledge and competences and always try find optimal assignments that suit your profile.

Om tjänsten
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.

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 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 & 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.

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
•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

Om verksamheten
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.


Submit your application as soon as possible, no later than March 30th. Interviews will be held continuously.

Start Date: As soon as possible or depending on candidate availability.

If you have any further questions, feel free to contact Robin Öz.