Regulatory CMC Associate to AstraZeneca
Poolia Sverige AB / Kemiingenjörsjobb / Stockholm
2021-02-01
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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 consultant assignment. 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.
Are you curious, creative, and open to new ideas and ways of working? As well as passionate about science and driven to always put patients first. Join AstraZeneca to 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 Visstid, mer än 6 månader
Publiceringsdatum2021-02-01ErsättningFast lön
Så ansöker duSista dag att ansöka är 2021-02-11
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "58646".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Körkort För detta jobb krävs körkort.
Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 5552712
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