Quality Assurance Advisor to AZ in Gothenburg

A one-year assignment as a Quality Advisor at AstraZeneca in Gothenburg is now available!

Are you interested in a challenging opportunity within the Development Quality function at one of the world’s leading pharmaceutical companies? We are currently looking for a Quality Advisor with a focus on GMP and a keen eye for detail to join AstraZeneca in Gothenburg. In this role, you will work with early product development manufacturing and packaging teams, and be responsible for the Development Quality release of externally manufactured Drug Products and Investigational Medicinal Products for clinical trials.

Does this sound like the role for you? Apply today!

Purpose, Offer and Benefits

This is a 1-year consultant assignment starting at the end of September. You will be employed by TNG during the assignment period.

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.

Your Responsibilities

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.

The Bigger Picture

The Development Quality function is responsible for quality oversight of the pharmaceutical development activities in AstraZeneca. 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.

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.

Our Expectations

• 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.