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Quality Assurance Associate (H/F/X)

September 16th 2022

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

Mission Description

You will report to the Technical leader compliance
 
You will be part of a team of 8 persons
 
In this role, you will be accountable for: 
 
  • 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
 

Candidate profile

Master of Lifesciences
 
Required:
  • At least 2 years of experience in the pharmaceutical industry in a similar role
  • Good knowledge of the pharmaceutical sector, Quality Assurance principles, GMP and ICH guidelines 
  • Very good communication skills both in French and English (contacts with clients, authorities, Audit management) 
  • Very good writing skills both in French and English
  • At ease with office IT tools

Offer

Quality Assurance Associate (H/F/X)

Contact Details

Send your application now (JOB335) to Isabelle Lebrun, Talent Acquisition Manager, to recrutement@quality-assistance.be or visit the Careers page on our website http://www.quality-assistance.com/careers.

Address: Technoparc de Thudinie 2, 6536 Donstiennes, Belgium