Qualified Person/QA Noord Brabant
Location: NetherlandsSIRE® 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 Noord-Brabant Netherlands.
- Auditing of contract manufacturers
- Assessment and release of manufactured medicinal products
- Release of incoming goods
- Assessment and processing of deviations and CAPA’s
- Training of employees with respect to GMP
- Set up a system of continuous improvement of quality (for example KPI, monitoring of IPC)
- Provide support to QA on an ‘ad hoc’ basis to assist in carrying out key QA responsibilities- including the provision of QA support to manage and escalate critical compliance issues through site QMS processes
- Strong affinity with, and awareness of, quality issues
- QP Qualified (conform EU Directive 2001/83/EC)
- Fluently in Dutch and English;
- Being flexible, assertive, can work with strict deadlines
The Company
The company produce products which are used both diagnostically and therapeutically in hospitals. These products are exported every week all over the world and has in recent years a significant growth.Role Description
In this job you will be responsible for the supervision, without any interference of third persons, of the business processes of pharmacy, related to the drug manufacturing license. With respect to the quality of the medicinal products, assurance of compliance to the Dutch Medicines Law and other applicable regulations. Together with the Head of Production maintaining an effective implementation, monitoring and maintenance of a GMP-compliant quality system.Responsibilities
- Design and implementation of a GMP - compliant quality system- Auditing of contract manufacturers
- Assessment and release of manufactured medicinal products
- Release of incoming goods
- Assessment and processing of deviations and CAPA’s
- Training of employees with respect to GMP
- Set up a system of continuous improvement of quality (for example KPI, monitoring of IPC)
- Provide support to QA on an ‘ad hoc’ basis to assist in carrying out key QA responsibilities- including the provision of QA support to manage and escalate critical compliance issues through site QMS processes
Requirements
- Experience with sterile product will be a plus- Strong affinity with, and awareness of, quality issues
- QP Qualified (conform EU Directive 2001/83/EC)
- Fluently in Dutch and English;
- Being flexible, assertive, can work with strict deadlines
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
