Scope

 

To face our constant growth, we are currently actively looking for a Quality Assurance Associate.

Our teams work on innovative biopharmaceutical products under development (preclinical and clinical phases). They are involved in projects outsourced by our clients.

Those projects are related to the development, validation and/or application of analytical methods based on a protocol for the characterisation and quality control of (bio)molecules.

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

Profile

Master's degree in Lifesciences

Required

  • At least 2 years of experience in the pharmaceutical industry

    • 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

Plus

  • Relevant experience in a similar role is an asset

What we offer

A sector compliant remuneration package including numerous fringe benefits (luncheon vouchers, hospitalisation and ambulatory insurance, pension plan, etc.)