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Quality Assurance Associate

November 19th 2019

QUALITY ASSISTANCE provides the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. Quality Assistance is a European benchmark company in the analytical sciences. With 35 years of expertise in the development and validation of analytical methods, cutting edge equipment and high level of Quality Assurance, Quality Assistance has gained the trust of the largest international pharmaceutical groups and numerous biotechnology companies based in Europe and the United States.

Mission Description

SCOPE

We assist our clients through non-clinical and clinical studies to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.
For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

YOUR MISSION

You will report to the Director 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

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

 

Offer

Quality Assistance offers you a job in:

  • The innovative human health sector 
  • A growing evolving company
  • A rigorous dynamic team
  • An international business environment
  • Premises in pleasant surroundings 

Quality Assistance also provides:

  • In-service training adapted to your profile and position 
  • Career path
  • A sector compliant remuneration package including numerous fringe benefits (luncheon vouchers, hospitalisation and ambulatory insurance, pension plan, etc.)
  • In addition to the fringe benefits received by all the personnel, you will also be provided with a company car.

 

Contact Details

Send your application (reference JOB191)  to Mrs Isabelle Lebrun, Talent Acquisition Manager, to recrutement@quality-assistance.be or consult the Careers page on our website http://www.quality-assistance.com/careers/jobs.

Address: Technoparc de Thudinie 2, 6536 Donstiennes, Belgium