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 organisation, based in Netherlands.
Role DescriptionAs Qualified Person you’ll be joining a diverse team and will be working together focusing on saving lives
ResponsibilitiesDisposition and involve in issue resolution related to manufacturing and testing of vectors and final product to EU destination.
Support site QA head in the implementation of Supplier Quality oversight program in EU. QP must be involved in all critical suppliers, including contract manufacturers and contract test laboratories.
Ensure that the marketing Authorization and Manufacturing Authorization or IMP Authorization requirements for the products have been met for the patient batch concerned.
Support site QA head in setting up a robust Quality Management System
Review all submissions (CMC) to regulatory authorities concerning the product (IMP/MP).
and maintenance of the Pharmacovigilance system in EU
Support inspection readiness plans
RequirementsRegistered QP in The Netherlands, experienced in the disposition of biologic products for clinical and /or commercial use
Minimum of 3 years’ progressive quality or manufacturing experience in a pharmaceutical, biotech, or biologics operation
Experience auditing CMOs
Experience with direct European Health authority inspections and interactions
Experience writing, evaluating and closing investigations, CAPAs and change control records.
In-depth knowledge of and ability to apply GMP
Proficient in MS Word, Excel, and Power Point
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.