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QA oversight for Quality Control activities - Belgium  

Mithra (company)


Posted on : 22 June 2017

Project Description

  • 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) 
  • Gather information to manage quality trend analysis/ quality review. This includes follow up and propose improvement actions 
  • Manage Quality Meeting with QC team to review quality trend analysis and propose improvement actions 
  • Review and approve Quality results and Certificate of Analysis 
  • Audit of third party (suppliers and contractors) : SOP write up, risk assessment, planning, audit and CAPA follow up 
  • Internal audit : SOP write up, risk assessment, planning, audit and CAPA follow up 
  • Participation to meetings and workshops 
  • Support inspection by authorities and customers 
  • Ensure quality system application and maintenance (deviation, change control, documentation, …) 
  • Ensure that annual training plans are followed and do the quality oversight of operational team training plans 
  • 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  

  • 2-5 years experienced in Quality assurance 
  • Good understanding on Analytical QC methods (Physicochemistry and/or Microbiology) 
  • Good knowledge of cGMP 
  • Master in Scientific Area (Biology, Chemistry/Bio-Ingenieur) 
  • Rigourous 
  • Critical 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