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 and will be part of a team of 9 people

As a Qualified Person you will be accountable for the following tasks:

  • Approving reports and certificates of Analysis (CoA)

  • Reviewing and approving the quality contracts with the customers and the suppliers (Quality Agreement)

  • Approving non-conformities, OOS and change controls

  • Managing Analytical methods (authorisation release into the system)

  • Participating to suppliers, clients audits and regulatory inspections when needed

  • Being the primary point of contact with Belgium Authorities

  • Working closely with QA compliance team

  • Ensure Regulatory watch on all new Regulations impacting Quality Assistance scope of activities

    • Overseeing the updates of regulatory policies and procedures on different channels: the Moniteur belge, ICH, Eudralex, AFMPS, FDA, GMP compliance, pharmacopeia’s, …

    • Reviewing, analysing and interpreting regulatory requirements in a clear and concise manner

    • Dispatching/distributing regulatory information to internal stakeholders for review

    • Performing gap assessments for proposed and effective regulatory requirements

    • Leading Regulatory Committee Meetings

Profile

Master’s degree in Industrial Pharmacy, certified by FAMHP as a Qualified Person.

You are

  • Stress resistant and proactive

  • Meticulous and details oriented

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

You have

  • Good organisational, planning and communication skills

  • Good ability to analyse and synthesise

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

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

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.