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DEPUTY QUALIFIED PERSON / QUALITY ASSURANCE ASSOCIATE - Belgium  

Company managed [?] Still accepting applications

Posted on : 11 June 2017

Project Description

Description:
As a Qualified Person in the Compliance Department team, you will assist and deputise for the regular Qualified Person in the following duties:   
  •   Approval of reports and certificates of analysis, GMP contracts, deviations and change requests 
  •   Management of analytical methods, outsourcing and importation of clinical batches, in compliance with applicable procedures 
  •   Verification of procedures on the management of deviations, change requests, samples, technical procedures, reagents and products, training, methods, specifications, outsourcing and importation of clinical batches   


As a Quality Assurance Associate, you will have (or participate in) the following tasks and  responsibilities:    
  •   Managing Standard Operating Procedures 
  •   Training personnel in procedures and the Quality System 
  •   Maintaining and developing the Quality System 
  •   Updating the Site Master File 
  •   Monitoring Key Quality Indicators and Key Performance Indicators 
  •   Promoting risk management and continuous improvement strategies 
  •   Drawing up the Quality Management Review (QMR) 
  •   Managing CAPAs 
  •   Carrying out and following up client and regulatory agency audits 
  •   Carrying out internal audits of facilities, processes and projects 
  •   Assessing quality contracts provided by clients 
  •   Monitoring quality in client projects 
  •   Advising clients on subjects related to quality 
  •   Qualifying providers     



Education and professional qualifications 
Master’s degree in Industrial Pharmacy, registered as a QP in Belgium  


Technical skills  
Required 
Theoretical knowledge of physicochemical and molecular and cell biology analytical techniques 


General skills 
Requires  
  •   Good knowledge of the pharmaceutical sector, Quality Assurance principles, GMP and ICH guidelines 
  •   Francophone, with a good knowledge of English, both written and spoken  



Experience

Required 
At least 2 years’ experience in a similar position