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: 2022-02-02 , 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 or Jimmy Wadie jimmy.wadie@randstad.se


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