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Perform Computer System Validation in both GAMP-4.

Ĝoordinated with System Analyst, Project Manager and Business Analyst to setup the pre validation and Validation environment to execute the scripts.

ĝocumented all the aspects of Systems validation lifecycle in accordance with the FDA regulations, Particularly 21 CFR Part 11 including Validation Plan and Protocol, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ).

Ěnalyzed the test scripts to check if it has covered the minimum functionalities, which need to be in compliance with 21 CFR.

Maintained a Requirements Traceability Matrix (RTM).

Ěctively participating in customization and validation of the eDMSwith FDA regulations and 21CFR.

Provide descriptive statistical analysis via tables, graphs and other tools for summarizing research results.Validate Assays that passed in QC back in R&D prior to release Design and execute experiments and analyze the resulting data in support of assay Development projects on MSD’s platform.

Ěuthor ITR’s and SOP’s for day to day testing.ĝeveloped Risk assessment and summarized mitigation methods.Ěct as a liaison between various groups such as Quality Assurance, Quality Control and Critical reagent.Included the qualification of HPLC dual UV detectors, photo diode array detectors, binary and quaternary gradient HPLC pumps Ğxecuted Operational Qualification and prepared summary reports on Agilent and Alliance HPLCs using Waters Millennium32.