I work assuring the quality of the results of the analytic assays used at Quality Control Department for the release of lots of drugs of biotechnical origin. I elaborate the politics, methodologies and procedures to evaluate the quality of the analytic assays since the design phase, implementation, validation and maintenance of the validated state with emphasis in the employment of experimental designs and statistical analysis. I review and I approve the associate documentation… Show more I work assuring the quality of the results of the analytic assays used at Quality Control Department for the release of lots of drugs of biotechnical origin. I elaborate the politics, methodologies and procedures to evaluate the quality of the analytic assays since the design phase, implementation, validation and maintenance of the validated state with emphasis in the employment of experimental designs and statistical analysis. I review and I approve the associate documentation (Procedures, protocols and reports). I am working now about how to evaluate the impact of the quality of the analytic results in the apparent variability of the production processes and how they impact in the correct decision about the approval or rejection of the drugs lots. Show less

Quality control of biopharmaceutical products.