Uppdrag 3PS (3rd party supply) CMC Administrator, AstraZeneca
Pema People AB / Biologjobb / Södertälje
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hela Sverige About the customer:
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.
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 (Södertälje), you will join a team of Regulatory system specialists within a global Operations Quality function based both in Gärtuna and Macclesfield, UK.
You will be responsible for the upload of manufacturing documentation provided by external partner companies into an existing document<t management system. Compliance with established good documentation practices such as document 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 documentation, 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 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 relatively new role and thus you will be expected to work alongside another 3PS CMC administrator participating in the development of any processes required to achieve the above.
Essential requirements:
• Educated to degree level in a science-related discipline
• Strong IT skills, experience of document management systems preferable
• Self motivated and capable of working under minimal supervision
• Excellent communication skills (written and oral)
Desired requirements:
• 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.
Are you the right person for the assignment?
Do not hesitate and contact me for further information; Markus Dahl at
markus.dahl@pemapeople.sePlease submit your CV and personal letter (in English) today!
Pema People AB är verksamt som bemannings- och rekryteringsföretag sedan 1997. Pema People AB är ett spännande företag i ständig utveckling. För närvarande sysselsätter Pema People ca 1300 personer. Vår framgång bygger på att vi lyckas rekrytera branschens bästa medarbetare och alltid med professionalitet och hjärta i fokus.
Vi matchar de bästa medarbetarna till rätt företag och uppdrag. Att vara extern medarbetare hos oss passar dig som på minsta möjliga tid vill skaffa dig mesta möjliga erfarenhet. Vi ger dig chansen att arbeta på attraktiva arbetsplatser där du utvecklar din kompetens.
Varaktighet, arbetstid
Heltid Full-time
Publiceringsdatum2018-02-01ErsättningFixed monthly salary, secure employment and great colleagues!
Så ansöker duSista dag att ansöka är 2018-02-16
Klicka på denna länk för att göra din ansökanKontaktMarkus Dahl
FöretagPema People AB
AdressPema People AB
Ektorpsgatan 6
60337 Norrköping
KontorsadressEktorpsgatan 6
Jobbnummer 3938205
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