Our client is a high-potential CRO based in Gosselies, Belgium. This fast-growing company offers a wide range of Immunology services with a strong commitment to develop customized solutions for its clients. The offerings include in vitro assays to assess the immunogenic potential of test molecules using T cell activation and proliferation assays as a surrogate marker for the induction of Anti-DrugAntibodies. On the immuno-oncology side, our client develops in vitro assays to assess the functionality of candidates. They continuously develops new cellular immunoassays to assist biotech and pharma companies directly in their product development. Other such collaborative services include protocol optimization and in-house training. Our client’s team works in an open-minded, science-driven and fast-paced environment. In order to support their growth, they are actively looking for to fill the following role:
As R&D QA Associate, you will work closely with the Director of Operations to set-up a quality management system tailored to the needs of the company. You will collaborate internally with the scientific teams to ensure a slow yet steady shift of mindsets towards GLP-like quality standards.
Main focus of the role is to build an operational excellence culture within the company, notably by setting up a quality management system tailored to the needs.
This will include among other things:
Create a job description per function, matching the company’s organigram
Build a training matrix for each R&D function and ensure implementation
Develop a SOP management system and ensure implementation;
Set-up an equipment management strategy, make sure lab equipment’s are maintained as needed and review service reports;
Closely follow the implementation of new worksheets/batch records;
Participate in writing/review of SOPs
Quality review and audit R&D data records, focusing on data quality and integrity;
Take part in audit from customer and follow-up implementation of corrective actions
Be involved in identifying quality processes that need to be improved and develop strategies with the team focusing on increased quality and traceability.
Scientific degree in Bioengineering/Industrial Pharmacy/Biomedical Sciences or equivalent
Minimum 3-5 years of relevant experience
Experience with setting up QA tools (tracking, record) is highly desired
Knowledge of ISO 9001 is a plus
Previous experience within a QA function is a plus
Good knowledge of Offices suite including Excel and Access.
Experience working with customers and service providers is a plus
Excellent knowledge of English and French
Skills and competencies
Deliver results and is committed to achieve challenging objectives