AstraZeneca Södertälje - Operations Regulatory CMC Analyst
Experis / Apotekarjobb / Stockholm
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hela Sverige Experis Engineering team are growing and we are now looking for you who wants to work as a consultant at AstraZeneca! AstraZeneca turn ideas into life changing medicines. Working at AstraZeneca means being entrepreneurial, thinking big and working together to make the impossible a reality.
About AstraZeneca
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. At AstraZeneca, innovation is about more than just research. We aim to stimulate continued creativity throughout our organisation by maintaining a culture in which our people feel valued, energised and rewarded for their ideas and contribution to our success - ideas which can make a difference in all aspects of our business.
Job description
AstraZeneca is operating as a supplier for divested products where the manufacturing licence is now owned by an external partner. As part of this relationship there is a requirement to ensure that AstraZeneca manufacturing network has full visibility and access to the current regulatory approved Chemistry Manufacturing and Controls (CMC) dossier for each country where the product is marketed. This is critical in ensuring that products are manufactured in compliance with the licences held by the third party licence holder.
Whilst this role is based in Gärtuna, you will join a team of Regulatory system specialists within a global Operations Quality function based both in Gärtuna and Macclesfield, UK.
Typical accountabilities:
You will be responsible for the upload of manufacturing documentation provided by external partner companies into an existing document
Additionally, you will be required to ensure that AstraZeneca's change control system is maintained to reflect regulatory assessments supplied by the third party. You will responsible for the upload of documents provided by external partner and communicate to relevant manufacturing sites.
You will be part of the 3PS Quality network and act as a key contact person for administration of documents related regulatory changes received from the external partner.
This is a new role and you will be expected to participate in the development of any processes required to achieve the above.
Essential requirements:
• Educated to degree level
• Strong IT skills, experience of document management systems preferable
• Self motivated and capable of working under minimal supervision
• Excellent communication skills (written and oral)
• High level understanding of GMP and working in a regulated environment
• High level understanding of CMC Regulatory knowledge
What we offer our consultant
As a consultant at Experis, we offer you the opportunity to develop your skills on behalf of some of the largest companies in several different industries. We have high expectations of you, but in return we offer excellent development and career opportunities. Here you also get a development plan, so both you and your consultant manager understands what you want to achieve and which skills you want to develop.
Our consultants have a secure job with all that implies in terms of overtime, vacation, pension and insurance under the collective agreement.
Application
Unfortunately, we can not receive your application by email, but apply through the application field through this advertisement, Please enter when you can be available and how you solve housing if you don 't live in the area were we are looking for candidates. The selection process is ongoing, so it's important that you submit your application as soon as possible.
If you have questions regarding the consultancy role you are welcome to email Candidate Specialist Julia at .
Welcome with your application!
Varaktighet, arbetstid
Heltid Contract
Publiceringsdatum2017-07-12ErsättningEj angivet
Så ansöker duSista dag att ansöka är 2017-08-23
Ange följande referens när du ansöker: 26661
Klicka på denna länk för att göra din ansökanKontaktJulia Järvholm
Julia.Jarvholm@se.experis.comFöretagExperis
AdressExperis
11181
11181 0180
KontorsadressKlarabergsgatan 29
Jobbnummer 3601930
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