Leiden - Quality Assurance specialist external manufactering

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The job of the (Senior) QA EM specialist is to enable from a quality perspective all activities needed to manufacture biological drug product (for vaccines and protein products) used in clinical trials. The (Senior) QA EM specialist works in a dynamic environment, where he/she should be able to make sound judgments based on quality principles and to provide compliant solutions to problems. The job holder should be an independent person and should be able to work constructively and negotiate with various parties throughout the organization, like Process Development, contract manufacturing, and Assay Development.Activities can be summarized as follows:• Carry out all QA duties related to the manufacturing of drug product for vaccine products and protein, including monoclonal antibodies. There duties include, but are not limited to:o Review and approval of 2nd/3rd Party deviations and CAPAs;o Review and approval of 2nd/3rd Party change controls;o Review of 2nd/3rd Party Master Production Records;o Review of 2nd/3rd Party Batch Production Records, including all supporting documentation (for example, test results);o Compilation of 2nd/3rd Party batch dossier for batch release; ando Review and approval of SOPs and Work Instructions;o Review and approval of raw material specification ...

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