Quality Assurance Advisor

We are searching for a Quality Assurance Advisor for a global pharmaceutical company.
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 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.


Responsibilities
• 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



Your profile
• 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


About the organisation
This position is a consultant assignment at our client via QRIOS Life Science & Engineering in Göteborg for one year. During this time you will be employed by QRIOS Life Science & Engineering.
QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER