QA validation expert
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 Noord-Holland Netherlands.
The CompanyOur client, one of the worlds largest pharmaceutical company based in Haarlem, has an interesting and challenging position for a process validation and improvement expert;
Role DescriptionResponsible for planning and executing process validations, media fillings, production line / operator qualification, as well as process improvement and product robustness initiatives. You work in dynamic project teams responsible for new project introductions, process improvements to comply with current legal requirements and ensure that the designs are in compliance with the international and company guidelines.
Responsibilities-risk assessment and prepare validation plans, protocols, execution of experiments and reporting;
-participate in the implementation of the validation activities;
-operational excellence and product robustness, responsible for critical assessment of processes and design or improvement plans, continuous process verification;
-maintain awareness of the legal guidelines for process validation requirements;
-you also participate in many other activities that are necessary for optimal quality or validation activities;
Requirements-bachelor bio process technology / technology, pharmacy, chemistry or similar;
-at least 2 years experience in a cGMP environment;
-experience with process improvement / validation or quality guarantee;
-knowledge of the GMP guidelines of the FDA / EU;
-excellent knowledge of the English language. Dutch is a big plus;
-team player with a proactive attitude;
Other information-permanent contract
-salary indication: € 2.700 € 4.300
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.