3PS (3rd party supply) CMC Administrator
Poolia Stockholm AB / Apotekarjobb / Södertälje
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hela Sverige On behalf of our client, AstraZeneca, we are now looking for a 3PS (3rd party supply) CMC Administrator for a temporary assignment in Södertälje. The assignment which is full-time will start ASAP and end 2018-12-31. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible. Cover letter and cv/resume must be in English.
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.
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 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/Desired requirements
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
ABOUT POOLIA LIFE SCIENCE & ASTRAZENECA
Poolia Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden's leading pharmaceutical and life science companies. So whether you're interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.
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. AstraZeneca is one of the world's leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
Varaktighet, arbetstid
Heltid Sex månader eller mera
Publiceringsdatum2018-01-31ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-02-16
Ange följande referens när du ansöker: 49285
Klicka på denna länk för att göra din ansökanFöretagPoolia Stockholm AB
AdressPoolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm
KontorsadressKungsgatan 57 A
Jobbnummer 3936348
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