Quality Compliance / Noord-Holland / Temporary / GMP
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-Holland Netherlands.
- Assessing and supervising the introduction of new products and product changes (Change Control)
- Guiding and preparing documentation when placing products with a new contract manufacturer (Site Change)
- Manage ongoing stability program
- Supporting the Qualified Person within (inter)nationally set stringent standards and company regulations
- Participate in audits at contract manufacturers together with the QP or Director QA
- Participate in projects
- Experience in deviations and outs of specs (OOS) in production processes
- Experience with pharmaceutical analysis methods
- Knowledge of European GMP guidelines
- Knowledge of the applicable European Registration Guidelines
- Excellent English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.
The Company
This pharmaceutical client is specialized in the development, production and sale of medicines and self-care products and part of the top ten pharmaceutical companies.Role Description
In this role you are responsible for monitoring and maintaining the quality (compliance) of bulk products, finished products and packaged products such that the EU GMP, the registration dossier, the national legislation (commodities law) and the organization guidelines are met.Responsibilities
- Supervising (subject matter) the products entrusted (part of the range), both routinely and during deviations or questions with a view to ensure compliance and quality- Assessing and supervising the introduction of new products and product changes (Change Control)
- Guiding and preparing documentation when placing products with a new contract manufacturer (Site Change)
- Manage ongoing stability program
- Supporting the Qualified Person within (inter)nationally set stringent standards and company regulations
- Participate in audits at contract manufacturers together with the QP or Director QA
- Participate in projects
Requirements
- BSc. pharmacy- Experience in deviations and outs of specs (OOS) in production processes
- Experience with pharmaceutical analysis methods
- Knowledge of European GMP guidelines
- Knowledge of the applicable European Registration Guidelines
- Excellent English
Other information
Are you capable of maintaining the quality compliance according to the GMP, the national and the organization guidelines? Let me know and maybe you will be the lucky person with a new position at an interesting pharmaceutical company.Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ria Bos.
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