Responsibilities: Experience in validating the Computerized System/Analytical Instrument. Extensive validation experience in 21 CFR Part 11. Good understanding of GxP standards. Good Knowledge in Data Integrity Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Traceability Matrix and Validation Summary Report (VSR). Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions. Excellent knowledge and good working experience in executing Gap Analysis and Change Control Process. Extensive experience in performing Risk Assessment. Good communication skills and English fluency. Requirements: Particle Measurement System. FT-IR Spectrophotometer. Gas Chromatography. Liquid Chromatography. Carbon Dioxide Headspace Analyzer. Differential Scanning Calorimeter. Metrohm. UV-Vis Spectrophotometer. Malvern Mastersizer. Mass Spectrometer. TruScan RM Analyzer. MTS System. Instron. ICP-OES Spectrometer. Mitutoyo Co-ordinate Measurement System. TOC- Total Organic Carbon. Sensitech TempTale Manager. Ellab Data Logger. Katalyst Healthcares and Life Sciences
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