Quality Assurance Advisor with Validation experience
Poolia Göteborg AB / Apotekarjobb / Göteborg
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hela Sverige Do you have GMP and validation experience? Are you interested in a challenging opportunity within the Development Quality function in one of the world's leading pharmaceutical companies? Then you might be the one! AstraZeneca Gothenburg are now looking for a Quality Assurance Advisor. The consulting assignment will start as soon as possible and go on to 2019-12-31. Please feel free to contact me if you have any questions before your application. Looking forward to hearing from you. Warmly welcome to Poolia and AstraZeneca.
about the consultant assignment
The arena
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 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.
Who you are
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
About AstraZeneca
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
What's in it for you?
• Collective agreement with Unionen (
https://www.unionen.se/rad-och-stod/om-kollektivavtal) • Strong benefits/offers designed for your need
• Individual career support
• Encouraging life career
• Broad professional network
• Committed consultant manager
Please feel free to contact me if you have any questions before your application.
Looking forward to hearing from you. Warmly welcome to Poolia!
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2018-06-01ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-06-11
Ange följande referens när du ansöker: 50347
Klicka på denna länk för att göra din ansökanFöretagPoolia Göteborg AB
AdressPoolia Göteborg AB
Kungsgatan 42
41115 Göteborg
KontorsadressKungsgatan 42
Jobbnummer 4180476
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