Quality Advisor, AstraZeneca Gothenburg

Job description
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 3 Quality Advisors with GMP focus to our Gothenburg team. 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. 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.

Responsibilities
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 internally or 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
Providing quality advice and approval of documentation related to equipments, facilities, IT systems and instruments e.g. maintenance, calibration, validation and change control
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.


Qualifications
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 Quality Systems and 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
Capable of making effective decisions
Demonstrate drive and energy in the role to make a difference
Demonstrate a high degree of personal credibility


Application
Deadline: 2022-03-24, selection and interviews will be ongoing. The position may be filled before the last day of application, therefore, apply as soon as possible.

For more information:
Please contact Birgitta Nyström birgitta.nystrom@randstad.se

About the company
Randstad Life Sciences is specialized in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many activities.

Randstad Life Sciences specializes in the field of science and is part of Randstad, the world leader in recruitment and consulting with operations in 38 countries. With this global network, in combination with our strong local foundation, we can offer a wide range of varied and developing assignments and jobs for you who are a specialist in life science. Our mission is to help you reach your true potential with your career in focus!