Operations Regulatory CMC Analyst, AstraZeneca Södertälje
Experis Engineering / Undersköterskejobb / Stockholm
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hela Sverige We are currently searching for a Operations Regulatory CMC Analyst for AstraZeneca in Södertälje. Do you have experience from working with Regulatory CMC affairs, and want to take your next career step witing life science at an exciting and reward-winning company? Please send in your application as soon as possible!
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.
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.
You will liaise with internal Regulatory specialists and external partners and be responsible for the upload of CMC documents into a document management system. Compliance with established good documentation practices such as version control, ensuring business approval and document format will be part of this work. Communication of any changes to this information, such as new market approved documents, to the relevant manufacturing sites is also a critical success factor.
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 partners and for communication to relevant manufacturing sites.
You will be part of the 3PS Quality network and act as a key contact person for ensuring dossier visibility.
You will be expected to work alongside another 3PS CMC associate participating in the improvement of 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 CMC knowledge
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 or any other characteristic protected by law.
What can Experis offer you?
As a consultant at Experis Engineering we are happy to offer you the opportunity to develop your knowledge within different fields at some of Sweden's leading companies. At Experis we are very proud of our consultants and together we find the right career-paths and challenges for you!
We do have high expectations on you, and in return we offer you great possibilities and opportunities in your work-life. We work together by setting plans for you on how we can collaborate for you to reach your own personal goals and develop professionally.
At Experis we strive for a good work and life balance. You will get a permanent employment in accordance with union agreements, including overtime payment, vacation, occupational pension and insurances.
Contact and application:
Please send in your CV as soon as possible through the link on the page. We do not have the possibility to receive applications through e-mail, but should you have questions about the job or the role as a consultant at Experis, please feel free to contact Talent Acquisition Specialist Camilla Forssberg at
Camilla.Forssberg@se.experis.comVaraktighet, arbetstid
Heltid Permanent
Publiceringsdatum2019-06-04ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2019-06-14
Ange följande referens när du ansöker: 6893c333-b596-
Klicka på denna länk för att göra din ansökanKontaktCamilla Forssberg
Camilla.Forssberg@se.experis.com +4687361923
FöretagExperis Engineering
AdressExperis Engineering
11828
11828 0180
KontorsadressSödermalmsallén 36
Jobbnummer 4826436
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