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.
You will report to the Technical leader 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)
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
Master in Lifesciences
At least 2 years' 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
Relevant experience in a similar role is an asset
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.
Visit https://www.quality-assistance.com/quality-assistance/life-quality-assi… 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-analytica… to learn more.