Quality Systems Specialist, AstraZeneca Sweden Biologics
AstraZeneca Södertälje / Kemistjobb / Södertälje
2017-02-23
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The individual acts as a Quality Systems Specialist for QS department. Involved in site and multi-site projects and supports, initiates, implements and maintains Quality Systems. The individual ensures that Quality Systems meets all compliance requirements. Issues and risks are timely flagged and escalated. The work is performed under direction of the Quality Assurance Lead/QP.
The individual is aware of current best Industry Practices and Inspectorate expectations.
The individual performing this function is a technically competent quality professional with previous experience in a Quality Control, Quality Systems, Validation and/or Quality Assurance role in a biotech or pharmaceutical company. The individual possesses a background in sterile manufacturing and preferably microbiology, statistics and biochemistry.
Essential Requirements
• University degree with a Masters in Pharmacy, Biology or (Bio) Chemistry or related sciences. Alternatively a Bachelor degree in cy, Biology or (Bio) Chemistry or related sciences with +10 years of experience.
• 10+ years of QA professional experience in Biologics or BioPharmaceutical industry with at least 5 years' experience in project management and multicultural environment.
• Experience with FDA inspections.
• Knowledge of multi-disciplinary management and operations.
• Fluently in English (speaking and writing) and able to understand Swedish.
• Membership of a professional body e.g. ISPE, PDA, NIA, or relevant organisations.
• Knowledge on Quality Systems.
Desirable Requirements
• Immunology experience.
• Cross functional negotiation skills.
• Previous experience in drug or biologics manufacturing and testing.
We have an exciting opportunity for you to join our new biologics manufacturing plant at Gärtuna, 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 new manufacturing plant will focus on the filling and packaging of protein therapeutics for late stage clinical and commercial products.
Our initial plan is to have the first clinical fills in Q4 2018 and first commercial fills in Q4 2019. On top of that we will be starting testing in our micro lab in 2017. In the long term, this site could create up to 250 highly skilled jobs. This site is intended to be the biologics site for late stage clinical and a vast amount of commercial products to increase the biologics manufacturing capacity and meet the needs of the maturing AstraZeneca pipeline. This newly build site will play a big role in our plans for the future.
If you're inspired by the possibilities of science to make a difference and ready to discover what you can do - join us
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.
Publiceringsdatum2017-02-23Så ansöker duSista dag att ansöka är 2017-03-08
Ange följande referens när du ansöker: R-004073
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje
KontorsadressKarlebyhus, Astraallén
Jobbnummer 3338045
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