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Quality Assurance Advisor

Ref: ZL_MODIS_001122

veckor sedan

Modis Life Science is now looking for a Quality Assurance Advisor for a consultancy assignment at AstraZeneca in Gothenburg. The assignment will last for 12 months with start in beginning of 2020. As a consultant you will be hired by Modis. If you find the assignment interesting send your application as soon as possible, no later than December 12.

About the company

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 to our Gothenburg team. AstraZeneca´s pharmaceutical development organizations deal with 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. You will also have the possibility to contribute with expert advice to the pharmaceutical development functions and to the delivery of our pipeline of exciting new medicines.

The role

In your role you will have a lot of interactions with internal and external stakeholders as well as with vendors and suppliers.

  • Provide QA advice into internal/external manufacturing activities of Drug Product and patient medication
  • Perform QA release of internally/externally manufactured and packed Drug Product as part of the Supply Chain to clinical trials
  • Support the pharmaceutical development functions with investigations of deviations, complaints, changes and other quality and compliance decisions in the development projects
  • Provide QA support to pharmaceutical development project with daninterpretation of GMP regulations
  • Provide appropriate QA input to business improvement projects
  • Collaboration with AstraZeneca QA colleagues globally

The role may also include

  • Responsible for QA advice and approval of documentation related to manufacturing equipment and facilities to ensure compliance, including maintenance, calibration, validation and change control
  • Interpret, trend and report compliance data, to measure and improve quality standards within the pharmaceutical development functions.
  • Develop QA Agreements with suppliers or contractors delivering services or products to the pharmaceutical development Supply Chain.

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
  • Comprehensive understanding of the pharmaceutical/drug development process
  • Good communicator with experience of interacting effectively across interfaces
  • 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 a high degree of personal credibility

For questions, please contact Cecilia Larzon (cecilia.larzon@modis.se)

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