QA Manager / QP | GMP | East-Flanders
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical organisation, based in Oost-Vlaanderen Belgium.
The CompanyThey are a global leader in providing high-quality drug development solutions for pharma clients.
Role DescriptionAs Quality Assurance Manager and Qualified Person you are responsible for the business unit that manufactures and controls biological drug substances and related final products. Your main responsibility will be to implement, maintain and manage a GMP compliant Quality Management System. You will report directly to the Quality Assurance Director.
Responsibilities- Manage the QMS of biological drug substances and related final products (buffer preparation, upstream and downstream processes);
- Manage the CAPA system: changes, deviation, non-conformities;
- Manage, support and coordinate risk assessments;
- Manage the supplier qualification process (materials and services);
- Support and review the qualification of production equipment, test equipment and cleanroom facilities;
- Lead audits and inspections;
- Review and approve batch records;
- Release batches of biological intermediate products, drug substances and related final products;
- As a Qualified Persons, certify final products;
- Promote GMP-awareness.
Requirements- A Master of Science degree in a scientific discipline;
- You are a registered QP
- 5-10 years of quality assurance experience in pharma or biotech;
- Knowledge of GMP quality systems
- Knowledge of biological process development and manufacturing is a real asset
- Fluent in Dutch and English, written and spoken.
Other informationOur client provides:
- a position with responsibility within a dynamic company;
- an envrionment where professional and personal development is supported;
- a salary, depending on your experience, based on market practice.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.