Quality Systems Manager EMEA
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 Utrecht Netherlands.
- Provide quality oversight and establish quality agreements with service providers
- Overseeing product issues (recalls and complaints)
- Develop and improve a new QMS
- Prepare, review and approve reports both internally and externally required by regulatory agencies and customers
- Lead in operational in excellence initiatives companywide, in order to obtain overall improvement
- Assist in oversight of external QP/RPs to ensure compliant product release
- Play an active role in obtaining and maintaining any required pharmaceutical licences for marketing products in Europe
- Full understanding of GDP and GMP
- Understanding of ISO130485
- Experience in developing and improving QMS
- You have at least 5 years of experience in QA/RA regulated environment, preferably in a postion with similar responsibilities
- Fluent in English (Verbal/written)
- You have experience in vendor/supplier audits
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Seppe Verhoeven.
The Company
Our client is a professional pharmaceutical organisation who produces medicines in het USA. At the moment they are expanding to Europe with their head office near Utrecht station.Role Description
This exciting role consists of developing in-country QMS troughout Europe, as a sub part of the Global QMS. For the enabling of the Commercial Operations, you wil be responsible for the acquirement of the required license infrastructures (WDA, MIA, Exploitant, ...)Responsibilities
- Developing a new quality assurance program in Europe, you will get an active role withing training and audits- Provide quality oversight and establish quality agreements with service providers
- Overseeing product issues (recalls and complaints)
- Develop and improve a new QMS
- Prepare, review and approve reports both internally and externally required by regulatory agencies and customers
- Lead in operational in excellence initiatives companywide, in order to obtain overall improvement
- Assist in oversight of external QP/RPs to ensure compliant product release
- Play an active role in obtaining and maintaining any required pharmaceutical licences for marketing products in Europe
Requirements
- Master degree in Life Sciences- Full understanding of GDP and GMP
- Understanding of ISO130485
- Experience in developing and improving QMS
- You have at least 5 years of experience in QA/RA regulated environment, preferably in a postion with similar responsibilities
- Fluent in English (Verbal/written)
- You have experience in vendor/supplier audits
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Seppe Verhoeven.
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