Quality Systems Specialist, AstraZeneca Global Biologics Sweden

AstraZeneca / Kemiingenjörsjobb / Södertälje
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AstraZeneca is one of the world's most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that improve patients' lives and benefit society.

We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives while they feel valued, energized and rewarded for their ideas and creativity. If you're inspired by what science can do to make a difference to patients' lives and ready to discover what you can do - join us.



AstraZeneca is establishing a Biologic fill, pack and finish facility in Södertälje. The purpose-built facility will supply the next generation of biological drugs from the AstraZeneca pipeline supporting the acceleration of the biologics portfolio. The facility is currently in qualification. Processes are being developed to be ready for late stage clinical and commercial supply in 2019.



We have now an exciting opportunity for you to join the Biologics Quality team in Södertälje as a Quality systems specialist.



Main Duties and Responsibilities

The Quality Systems specialist works to implement, develop, monitor and improve business processes which support site deliveries. The role offers a broad range of tasks, contacts and the opportunity to build and influence the site quality culture. Since the site is new to the network the work frequently also includes interaction with other EU and US sites to develop shared processes.



The Quality Systems responsibilities include key processes such as Product Quality Reviews, Change Management, Site Master File, KPI reporting and Management Review. Interpretation of corporate standards and GMP requirements is together with the application of Quality Risk Management key to support the business. The Quality Systems specialist reports to the Quality Systems and Projects Director.



Essential Requirements

o University degree with a Masters in Pharmacy, Biology or Chemistry or related sciences.

o Experience from Quality roles in the pharmaceutical industry, including sterile manufacturing.

o Highly knowledgeable in GMP frameworks.

o Communication skills and experience of multi-disciplinary operations.

o Fluent in Swedish, a high level of English language comprehension and the ability to author grammatically correct documents.

o Ability to work in a start-up environment being curious about exploring new solutions while having a clear focus on customer value.



Desirable requirements

o Experience from working with biologics products, device and combination products

o Meeting Swedish requirements for the Qualified Person role

o Experience from different roles in pharmaceutical industry



If you are interested, apply now!

For more information about the position please contact Rickard Fjaestad Gustafsson, +46 709 154422

Welcome with your application no later than 2 September, 2018.

Interviews will be initiated during the application period as appropriate.



AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Varaktighet, arbetstid
Heltid Permanent

Publiceringsdatum
2018-08-10

Ersättning
Not Specified

Så ansöker du
Sista dag att ansöka är 2018-08-31
Ange följande referens när du ansöker: R-033700
Klicka på denna länk för att göra din ansökan

Kontakt
AstraZeneca therese.lindberg@astrazeneca.com

Företag
AstraZeneca

Adress
AstraZeneca
15185
15185 0181

Kontorsadress
Astraallén

Jobbnummer
4283417

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