Quality Assurance Specialist

Consultancy role for AstraZeneca.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialisation 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, energised 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 organisations manage 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.
The role
As a Quality Advisor, you will work with early product development manufacturing and packaging teams and be responsible for Development Quality release of 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. 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. In your role, you will have interactions with internal and external stakeholders.

Typical Accountabilities:

* Responsible for quality Release of manufactured Drug Product, Investigational Medicinal Product for clinical trials.
* Providing quality input to Manufacturing, Packaging, Labelling & Distribution activities.
* Providing 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.
* Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects.
* Provide appropriate Quality Assurance input to business improvement projects.
* Operate as part of a global organisation with an integrated mindset to create an organisation with common processes and ways of working.

Requirements:

* Degree in pharmacy or engineering (specialising in Pharmaceuticals)
* 3 years' experience of working within a pharmaceutical GMP environment.
* Broad understanding of Quality Systems and GMP and related activities to Investigational Medicinal Product (IMP).
* Experience of documentation, deviations, changes, and other quality and compliance decisions in the development projects.
* Fluent in written and spoken English.

Desirable:
* Experience preferably within a pharmaceutical manufacturing organisation.
* Understanding of Project Management processes.
* Good team work and networking skills.
* Capable of making effective decisions.
* Demonstrate drive and energy in the role to make a difference.
* Demonstrate a high degree of personal credibility.
* Comprehensive understanding of the pharmaceutical/drug development process.
* Good communicator with experience of interacting effectively across interfaces.



What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

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