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Sarah De Laet posted a job: nXt-IT is looking for a 2 Site Compliance Network Members start: asap duration : 1 jaar location : brussel ref nr 1955 "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 Hou aub wel rekening met enkele belangrijke vereisten: • Level -> Junior/advanced (geen schoolverlaters) • Inhoudelijk snel inzetbaar • Kennis van LIMS • Interesse in PC systemen More info? jobs@nxt-it.biz ref nr 1955" | |||||
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Thursday, September 12, 2013
New job nXt-IT is looking for a 2 Site Compliance Network Members start: asap duration : 1 jaar location : brussel ref nr 1955
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