Quality Operations Lead/Qualified Person, Sweden Biologics
AstraZeneca AB / Chefsjobb / Södertälje
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hela Sverige 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.
At Sweden Biologics we work as partners in bringing life changing medicines to patients, sharing and benefiting from each other's strengths. Our team is made up of a Global network of individuals from our business.
We have now an exciting opportunity for you to join our new Biologics manufacturing plant at Gärtuna, Södertälje.
We are looking to hire a Quality Operations Lead, as the Quality Operations Lead you are responsible for leading the function and to drive compliance improvements. You will lead significant cross-functional projects, manage the development and implementation of improved ways of working to deliver robust Quality Assurance.
You are to become a Qualified Person releasing our biopharmaceutical products, providing quality oversight and expert subject knowledge. You and your team will co-operate in cross-functional teams daily. You will report to the Site Quality Director and be part of the site Quality Leadership Team.
Main Duties and Responsibilities
* Lead the Quality Operations Function and ensure delivery against targets
* Provides direction, development, and performance management to the Quality Assurance professionals within the function
* Act as Qualified Person. Responsible for product & material release decisions, operating within product dossiers and AstraZeneca Global standards
* Ensures compliance with AstraZeneca quality principles, current Good Manufacturing Practice and regulatory requirements
* Acting as an escalation point for complex issues, managing issues through to resolution
* Leads significant cross-functional projects, manage the development and implementation of improved ways of working
Essential Requirements
* Competent People Manager with several years' experience of leading teams
* Master degree in science/technical field such as Pharmacy/Pharmaceutical Sciences, Biochemistry or Chemistry with at least 160 p/240 hp, satisfying the requirements for becoming a Qualified Person in accordance with LVFS 2004:7
* Considerable experience in supervisory/managerial roles within Quality Assurance in the Pharmaceutical Industry
* Understanding of current Good Manufacturing Practice regulations of major regulatory authorities/organisations
* Possesses a background in aseptic/sterile manufacturing
* Significant experience with Health Authority Inspections (FDA, MPA)
* Possess excellent communication skills, ability to interact at multiple levels within the organization
* Able to speak, read and write Swedish fluently and English at an advanced level.
Desirable Requirements
* Having several years' experience acting as a QP
* Has extensive experience across a range of business areas
* Has experience of applying LEAN methods and ways of working
If you are interested, apply now!
For more information please contact Malin Claesson, 08-55252641.
Welcome with your application no later than September 4, 2017.
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
Publiceringsdatum2017-08-15ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2017-08-22
Ange följande referens när du ansöker: R-012495
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
Helena.Kallin@astrazeneca.comFöretagAstraZeneca AB
AdressAstraZeneca AB
15185
15185 0181
KontorsadressBox 291, 151 24 SÖDERTÄLJE
Jobbnummer 3642591
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