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Sarah De Laet has started a discussion: nXt-IT is looking for a site compliance network consultant start : asap duration : 31/12/2013 location : Brussels ref nr 2007 "Expected Activities: Site Compliance Network Member tasks related to transfers (Vetter): * To make a Drug Product Module 3 of the CTD * Determine the data needed to support a variation & prepare variation package * Determine the expected timelines to get an approval of variation/registration * Support the implementation of a change at the site Desired Education level: Industrial Pharmacy/Bio-Engineer Experience/Knowledge: Contents of the Common Technical Document Module 3/Drug Product Regulatory guidelines/directives related to drug products of small molecules, knowledge for biologics/vaccines is an advantage Skills to translate a technical document into a clear, comprehensive document reflecting the compliance with the guidelines/directives Ability to write a “story” explaining a variation with supporting data to prove the new situation is equal to the old situation based on guidelines/directives, being the quality overall summary. Project management, i.e. follow-up different technical teams making sure data to support a variation are available within a fixed deadline Personal Skills: Fluently writing and speaking English Discipline Structured way of working Good logic thinking Team spirit Ability to work independently More info? jobs@nxt-it.biz ref nr 2007" | ||||||
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Thursday, October 17, 2013
New discussion nXt-IT is looking for a site compliance network consultant start : asap duration : 31/12/2013 location : Brussels ref nr 2007
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