QA System and regulatory
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Luik Belgium.
This healthy and growing company develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO (contract development and manufacturing organization).
ROLE DESCRIPTION
In your role you will be responsible for the pharmaceutical quality system and regulatory intelligence. Is your passion to review changes and improve quality systems? Are you driven to make sure that everything meets the regulatory requirements? Then this is the job for you!
RESPONSIBILITIES
You will be responsible for maintaining and improving the PQS and maintaining an appropriate level of compliance to the companies quality management system. Also you will be responsible for assessing impact of the regulatory updates. Next to that you will be responsible for the following:
- Document control
- Manage GMP certificates
- Ensure the updating of the Site Master File
- Review of the Quality Technical Agreement
- Preparing, introducing follow-up and putting applications for exemption
- Ensure the verification and approval of the quality agreement and the technical agreement
- Ensure the adequate management of validation, deviation and potentials CAPA's
- Preparing, introducing follow-up and putting applications for exemption
REQUIREMENTS
- 5 years experienced in Quality assurance
- Bachelor in the pharmaceutical industry / Life sciences (or relevant)
- RA experience is an big plus!
- Good knowledge of cGMP
- Good knowledge in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
