Regulatory CMC Associate to AstraZeneca
Dfind Science & Engineering AB / Apotekarjobb / Stockholm
2017-09-26
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On behalf of AstraZeneca we are now looking for candidates for a 12 month consultant assignment within CMC Regulatory Compliance & Stability, Operations Quality to AstraZeneca.
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 AstraZeneca is more than one of the world's leading pharmaceutical companies. AstraZeneca has 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.
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. You may also support externalisation projects and transfer of CMC documentation to external partners. The role will be based in Södertälje and you will work in a team of 8-10 people.
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
• Knowledge of information and document management technology and electronic/paper publishing software
• IT software skills
• 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
Business: Dfind Science & Engineering
City: Södertälje
Job type: Full time
Deadline for applications: 2017-09-29
More information: Sofie Önnestam,
sofie.onnestam@dfind.se, 073 343 99 61
Please send your application in English.
We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.
Organization/Business description:
Dfind Science & Engineering is part of Randstad, one of the Nordic region's largest specialists within staffing, recruitment and outplacement.
Dfind Science& Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!
All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-09-26ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-09-27
Ange följande referens när du ansöker: 201084161
Klicka på denna länk för att göra din ansökanKontaktSofie Önnestam
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Regeringsgatan 65
10724 STOCKHOLM
KontorsadressRegeringsgatan 65, 10724 STOCKHOLM
Jobbnummer 3718414
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