Description
A Validation Engineer with proven success working with major pharmaceutical companies and diversified experience across all aspects of the industry: Quality control manufacturing regulatory compliance and multiple departmental operations. Consistently demonstrating a high level of experience in all aspects of the development execution and close out of commissioning/qualification programs using process design documentation process flow diagrams piping and instrument diagrams specifications calibration activities and data sheets. Experience with Automation systems (Delta V BMS etc.) and validation of Lab Instrumentation Systems. Extensive experience with investigations/CAPAs/Deviations/Non-Conformance GAP analysis and remediation processes. Extensive knowledge of the pharmaceutical drug process science and risk based validation approach and FDA audit procedures. Good knowledge of GMPs cGAMP GLPs ICH CFR and global regulations. Process validation Batch Records Validation Life Cycle Planning and Execution Final Reports URS/FRS DS Risk Assessment GAP Analysis Comprehensive Product Assessment and Trending Deviation Non-conformities CAPA Remediation Process Change Control Master Validation Plans IOPQ Summary reports and Engineering studies
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