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

Your profile

Scientific background

Required

  • 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

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 environment.

  • 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.