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 12 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 Belgian Authorities

  • Working closely with QA compliance team

  • Ensure regulatory monitoring 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, FAMHP, 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

Your profile

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

You are

  • Stress resistant and proactive

  • Meticulous and detail-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 physico-chemical and molecular and cell biology analytical techniques

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

Why join Quality Assistance?

We are a true career partner.

  • We accelerate people’s access to new medicines.

  • We offer an inspiring work-life balance in a human scale environmeant.

  • We care about mutual respect, assistance and communication.

  • We listen to your needs and your suggestions.

  • We offer a market-competitive remuneration package including numerous fringe benefits. You will also be provided with a company car.

Visit https://www.quality-assistance.com/quality-assistance/life-quality-assistance to learn more.

About Quality Assistance

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. 

For each client 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.

The company holds a unique position on the market with all its laboratories on one site, 190 highly qualified professionals and over 35 years’ expertise at the forefront of analytical sciences.

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit https://www.quality-assistance.com/quality-assistance/leading-analytical-cro to learn more.