Regulatory CMC Associate to AstraZeneca
Poolia Sverige AB / Kemiingenjörsjobb / Stockholm
2020-11-09
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➡️ Klicka här för den senare publicerade platsannonsen "Regulatory CMC Associate to AstraZeneca" (publicerad 2021-08-30) ⬅️
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hela Sverige On behalf of our client, AstraZeneca, Poolia Life Science is now looking for a Regulatory CMC Associate for a long consultant assignment. 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 will be based in Södertälje (Gärtuna) and you will work in a team of 8-10 people. Selections and interviews are held on an ongoing basis, so please submit your application as soon as possible.
Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca's global supply chain. We are looking for Regulatory CMC Associates to our product teams located in Södertälje.
We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.
THE ROLE
As a Regulatory CMC Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs. You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.
You may also support externalisation projects and transfer of CMC documentation to external partners.
Minimum Requirements - Education and Experience:
• Degree in Chemistry or Pharmacy or Chemical Engineering
• Fluently spoken and written English and Swedish
• Experience in Post Approval Regulatory CMC including CMC documentation authoring
• Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs
Skills and Capabilities
• Able to work collaboratively with customers and colleagues to achieve optimum outcomes
• Knowledge of information and document management technology
• 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
• Excellent written and verbal communication skills ? Experience from using Document Management systems
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2020-11-09ErsättningFast lön
Så ansöker duSista dag att ansöka är 2020-11-18
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "57899".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 5436431
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