Consultant as Regulatory CMC Associate for AstraZeneca
Poolia Stockholm AB / Apotekarjobb / Södertälje
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Salem,
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hela Sverige Visa alla jobb hos Poolia Stockholm AB i Södertälje,
Ekerö,
Nykvarn,
Botkyrka,
Huddinge eller i
hela Sverige On behalf of our client, AstraZeneca, we are now looking for a Regulatory CMC Associate for a temporary consultant position in Södertälje. CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain. The assignment which is full-time will as soon as possible with the duration to May 31, 2019. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.
About AstraZeneca
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. 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 and energized for their ideas and creativity. CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global 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.
Requirements, Skills and Capabilities
Minimum Requirements - Education and Experience
• Degree in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
• Experience in Post Approval Regulatory CMC including CMC documentation authoring is desirable
Skills and Capabilities
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Ability to work with short and/ or changing timelines
• Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
• Good communication skills
• Knowledge of information and document management technology and electronic/paper publishing software
• IT software skills
ABOUT POOLIA & ASTRAZENECA
Poolia take good care of our consultants and we offer social activities, as well as help in planning your future career. Your consultant manager is well experienced from your field, and knows how to get the most out of your assignment. As a Poolia employee, you are included in the requirements concerning agreements on terms of employment by Unionen. Moreover, you get a grant for working out at your choice of place. You are also covered by a health insurance. 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
Publiceringsdatum2018-04-09ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2018-04-19
Ange följande referens när du ansöker: 50023
Klicka på denna länk för att göra din ansökanFöretagPoolia Stockholm AB
AdressPoolia Stockholm AB
Kungsgatan 57 A
10124 Stockholm
KontorsadressKungsgatan 57 A
Jobbnummer 4069800
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