Quality Assurance Specialist

Job description
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 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  

We have an exciting opportunity for a Quality Advisor role, in the Site Quality Gothenburg team, who’ll be the prime source for quality & compliance advice and providing quality support to the science functions and throughout the drug development process chains. 
This is a great opportunity for you who are strong in quality and like to work close to development, Good Manufacturing Practice and making sure quality is assured when delivering new products  

This is a consulting assignment with Randstad Life Sciences. 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 social activities.



Responsibilities
The role
Working in the Site Quality team means you will work closely with the internal assets/facilities, teaming up with the pharmaceutical development functions and be involved in cross business processes. To build strong relationships with these functions knowing their business is key, to give support to projects and develop ways of working that builds for success. 

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 use your problem solving skills to resolve any quality issues. You will participate and contribute to continuous improvement projects with the aim to standardize and simplify our internal processes.

Typical Accountabilities: 
Responsible for quality release of manufactured Drug Product, Investigational Medicinal Product for clinical trials  
Support the pharmaceutical development functions with investigations of deviations, changes and other quality and compliance decisions in the development projects related to drug product
Providing quality advice and approval of documentation related to equipments, facilities, IT systems and instruments e.g. maintenance, calibration, validation and change control  
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  
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
Demonstrates understanding of international quality systems regulations, concepts, industry practices to adopt best in class processes 
A comprehensive understanding of GMP regulations, the pharmaceutical development process and supply chain process would be advantageous 
Ability to work in a fast-paced environment, meet deadlines, and balance multiple priorities. Independently motivated, detail-oriented, and “can-do” attitude 
Excellent team working and networking skills and encourages team effectiveness 
A good communicator with experience of interacting effectively across interfaces collaborating internally 
Fluent in written and spoken English


About the company
About randstad life sciences
Randstad Life Sciences is specialized in competencies 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.

Deadline: 2023-09-14, selection and interviews will be ongoing.
For more information: Please contact Katan Ali, katan.ali@randstad.se