Scope

 

To face our constant growth, we are currently actively looking for a Deputy Qualified Person/Quality Assurance Associate

You will work on innovative biopharmaceutical products under development (non-clinical and clinical phases).

You will be part of a team 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

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

Profile

Master’s degree in Industrial Pharmacy, registered as a QP in Belgium.

Required

  • First experience in a similar position

  • Theoretical knowledge of physicochemical and molecular and cell biology analytical techniques

  • Good knowledge of the pharmaceutical sector, Quality Assurance principles, GMP and ICH guidelines

  • Fluent in French with a good knowledge of English, both written and spoken

What we offer

  • 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.