Quality Assurance Advisor to AstraZeneca Gothenburg
Alten Sverige AB / Sjukhusteknikerjobb / Göteborg
2018-03-23
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hela Sverige ALTEN Pharma in Gothenburg is looking for
QUALITY ASSURANCE ADVISORS for consultancy assignments at AstraZeneca in Gothenburg.
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 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 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 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
ABOUT ALTEN:
For over 20 years, ALTEN has developed its business by keeping to the core values ??that have built up the company's success. Every year, hundreds of ALTEN consultants have been given the opportunity to embark on challenging technical projects for our customers. ALTEN has a tradition of developing products in many areas, and history in Sweden is based primarily on skills in mechanics, software and electronics. Thanks to a successful concept in which we utilize the expertise of experienced consultants and develop young abilities towards a successful career, we have gained ground in many industries. Our Pharma initiative is based on the same successful concept with the same strong structure, but in a new exciting industry and a new field of expertise that includes knowledge in chemistry, biotechnology and biomedicine.
As an employee at ALTEN, we offer you a competitive salary based on your performance and work experience. You also have the opportunity to influence your assignments, different benefits and your overall working environment as well as choose your career path. We offer a wide range of internal trainings and an opportunity to plan for an international career. It is our conviction that genuine commitment is created through choice and the ability to influence your own personal development - our business model provides that opportunity. This freedom of choice enables us to offer our clients the most committed consultants, regardless of assignments. At ALTEN, we believe in growing together!
For questions about the position, please contact Rickard Westergen, Business Manager Pharma, at
rickard.westergen@alten.se.
Varaktighet, arbetstid
Heltid Tillsvidareanställning
Publiceringsdatum2018-03-23ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-04-06
Klicka på denna länk för att göra din ansökanKontaktHR-avdelningen, Alten
FöretagAlten Sverige AB
AdressAlten Sverige AB
Theres Svenssons gata 15
41755 Göteborg
KontorsadressTheres Svenssons gata 15, Göteborg
Jobbnummer 4041806
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