Regulatory CMC Associate at AstraZeneca, Södertälje
Modis Sweden AB / Kemistjobb / Södertälje
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hela Sverige Modis is a staffing & recruiting company and is part of the Adecco Group, the world 's leading HR-solutions provider across 60 countries. This scale and scope ensures Modis is truly a global community. Our mission is to be the Leading Professional Services Company by finding the right match between you as a candidate and you as a customer. We are a team with various and complementary backgrounds within Life Science, Engineering and Technology. We can ensure that we understand our customer needs and we can ensure that we understand the competence-profiles of our applicants and candidates.
We are now seeking for a Regulatory CMC Associate to AstraZeneca in Södertälje. This is temporary consultant assignement until end 2019.
About the customer
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 severe diseases. But we 're more than one of the world 's leading pharmaceutical companies. At AstraZeneca, we 're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
Operations Regulatory is a global function within Global Quality Supply Chain, that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the world-wide AstraZeneca supply chain.
The role
The Regulatory CMC Associate generates CMC documentation presented in the required format to the agreed timetable, for worldwide submissions. You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory documentation. You may also coordinate assembly of submission-ready documents to support lifecycle submissions.
You will keep business wide electronic systems up to date to be consistent with regulatory submissions and commitments.
The role will be based in Södertälje, Sweden, and you will work in a team of 8-10 people.
Minimum Requirements - Education and Experience
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Degree in Chemistry, Pharmacy or Chemical Engineering
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Fluently spoken and written English and Swedish
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Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
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Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable
Skills and Capabilities
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Able to work collaboratively with customers and colleagues to achieve optimum outcomes
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Ability to work with short and/or changing timelines
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Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
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Good communication skills
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Knowledge of information and document management technology and electronic/paper publishing software
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IT software skills
Please submit your application today, or by latest 2019-03-22, by attaching your CV and personal letter (interviews are held continuously).
If you have any questions about the assignment, do not hesitate and contact Markus Dahl (
markus.dahl@modis.se).
Varaktighet, arbetstid
Heltid Full time (40h/week)
Publiceringsdatum2019-03-18ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-03-22
Klicka på denna länk för att göra din ansökanKontaktMarkus Dahl
FöretagModis Sweden AB
AdressModis Sweden AB
Hamngatan 13
11146 Stockholm
KontorsadressHamngatan 13
Jobbnummer 4674035
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