Quality Assurance Advisor to AstraZeneca R&D in Gothenburg
Pema People AB / Apotekarjobb / Göteborg
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We are now looking for two Quality Assurance Advisor for exciting long term assignments at AstraZeneca in Gothenburg. With the right profile and a lot of passion, this might be the start of a fruitful employment at Pema Engineering & Science.
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 Quality Assurance, for one of the world's leading pharmaceutical companies?
Pharmaceutical Development is the function within AstraZeneca that designs and delivers the active drug product required to support new medicines. The Quality Assurance group within Pharmaceutical development now wants to take in Quality Assurance contractors with a Good Manufacturing Practice (GMP) focus. AstraZeneca's Pharmaceutical Development organization deals with all facets of the process of turning a new chemical entity (NCE) into a medicine which can be safely and effectively used by patients. The Quality Advisor role has a broad range of responsibilities to ensure internal and external requirements are fulfilled for AstraZeneca projects in the development phase. Interactions occur among various internal functions and sites, but also with vendors and suppliers.
The role
In your work as a Quality Advisor at AstraZeneca you will have a broad range of responsibilities, the possibility to influence and to contribute to the pharmaceutical development function, and the delivery of our pipeline of exciting new medicines.
• Provide QA advise into Pharmaceutical Development internal/external manufacturing activities for Drug Product
• 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 and other quality and compliance decisions having a major impact on AstraZeneca development projects
• Provide Pharmaceutical Development projects with QA support, such as GMP risk assessment and interpretation of GMP regulations
• Provide appropriate QA input to business improvement projects
• Close collaboration with AstraZeneca QA colleagues globally
The role may also include
Responsible for QA 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 Pharmaceutical Development.
• Developing 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 as well as good skills in written and spoken Swedish
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
Are you the perfect match?
If you have any questions regarding the assignment, please contact Business Area Manager, Karin Lyckemalm at
karin.lyckemalm@pemapeople.se or 0720-808934
You apply by register below and attach CV and cover letter.
Last applicxation day is 2016-09-22, however selection is done continuously.
We are looking forward to receiving your application!
Pema People AB is staffing and recruitment Company that has been active since 1997. Pema People AB is a company in constant development and since 2016 we are present in Gohenburg. We match the best people to interesting companies and assignments. We offer our employees maximum experience in short time.
Pema Engineering & Science has extensive experience from both staffing and science. You can feel Confident in that we understand your business and the challenges you may face. We offer our staff a unique and solid employment solution, which forms the basis for a long-term cooperation.
Varaktighet, arbetstid
Heltid Preferred start date: 3rd of October 2016 End date: 31st of December 2017
Publiceringsdatum2016-09-19ErsättningPema Engineering & Science offer permanent employment, fixed monthly salary and great colleagues!
Så ansöker duSista dag att ansöka är 2016-09-22
Ansöker gör du genom att använda länken nedan.
Klicka på denna länk för att göra din ansökanKontaktKarin Lyckemalm
FöretagPema People AB
AdressPema People AB
Ektorpsgatan 6
60337 Norrköping
KontorsadressEktorpsgatan 6
Övriga kontaktuppgifter Jobbnummer 3055071
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