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Quality Assurance officer for Analytical transfer QA Oversight - Belgium  

Company managed [?] Still accepting applications

Posted on : 22 June 2017

Project Description

Responsibilities
  • Develops, assures and maintains the quality of the analytical methods and quality control processes 
  • Write up and review SOP for quality control activities (processes, analytical methods) 
  • Review and approve validation documentation (PV and RV) 
  • Provide recommendation for the strategy of methods transfer 
  • Ensure the transfer of analytical methods is performed according to the process and the plan and in conformity with the regulation 
  • Participation to meetings and workshops 
  • Support inspection by authorities and customers 
  • Ensure quality system application and maintenance (deviation, change control, documentation) in the framework of analytical transfer 
  • Deliver training for the team on quality topics 
  • Take part to investigation and CAPA with solution driven perspective 
  • Follow training as needed to fulfill function requirements 
  • Ensure critical topics are adequately and timely escalated to higher management 
  • Develop validation process of excel sheet 
  • Review and approve the excel sheet validation protocol and report  


Profile
  • 2-5 years experienced in Quality assurance and/or in Quality Control 
  • Experienced in QC Analytical method transfer 
  • Experienced in validation of analytical method 
  • Experienced in Validation of excel sheet 
  • Good understanding on Analytical QC methods (Physicochemistry and/or Microbiology) 
  • Good knowledge of cGMP 
  • Master in Scientific Area (Biology, Chemistry/Bio-Ingenieur) 
  • Rigourous 
  • Critical/Analytical mindset 
  • Good Communicator 
  • Good negociator  



What we offer
  • Varied and motivating responsibilities within a fast growing company
  •  An attractive salary package in line with your experience