Quality Assurance Advisor

at  Logent

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 a Quality Advisor with GMP focus and an eye for details 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.
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 (specializing in Pharmaceuticals)
• 2-3 years’ experience of working within a pharmaceutical GMP environment.
• 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.

• Experience preferably within a pharmaceutical manufacturing organization is desirable
• Understanding of Project Management processes is desirable
• Fluent in written and spoken English.

Softskills/personal skills:

• 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.
• Comprehensive understanding of the pharmaceutical/drug development process.
• Good communicator with experience of interacting effectively across interfaces.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
This is a consultant assignement for 12 months at AstraZeneca. During this time you will be hired by Logent
Platser
Göteborg
Anställningsform
Tidsbegränsad

Please refer the Job description for details