Quality Assurance Advisor at AstraZeneca i Göteborg.

Publicerad:
2018-05-14
Omfattning:
Full time
Kontakt:
Birgitta Nyström

Detaljer

Publicerad:
2018-05-14
Ort:
Göteborg, Västra Götalands län
Kategori:
Life Science
Specialisering:
Läkemedel, bioteknik & medicinteknik
Omfattning:
Full time
Referensnummer:
201148486
Sista ansökningsdag:
2018-05-24
Kontakt:
Birgitta Nyström

Beskrivning

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 consultant 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 interactions with internal and external stakeholders as well as with vendors and suppliers.

  • Provide QA advice into validation activities
  • 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 interpretation 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 validation, calibration, maintenance 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 with at least 3 years’ experience of working within a pharmaceutical GMP environment
  • Broad understanding of validation 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 the area of validation
  • Good team working and networking skills
  • Capable of making effective decisions
  • Demonstrate a high degree of personal credibility
Business: Dfind Science & Engineering

City: Gothenburg

Deadline for applications: 2018-05-20. Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application at your earliest convenience!

For more information contact: Birgitta Nyström birgitta.nystrom@dfind.se

Please keep in mind, e-mail applications will not be considered. Register your profile at Dfind Science & Engineering's webpage and send in your application there.

Organization/Business description:
Dfind Science & Engineering is a recruitment and consulting company within science and engineering. All our consultant managers and recruitment consultants have an education and work experience within the respective field. In combination with extensive knowledge of staff issues and solid experience of recruitment, this means that we understand our clients' need for both flexibility and the right skills.

Dfind Science & Engineering is since 2016 part of Randstad Group. With over 600 000 employees in over 40 countries Randstad is the world’s second largest company within recruiting and staffing.