JyothiK Posted December 4, 2018 Report Posted December 4, 2018 CSV Validation Analyst – 1 Location – Multiple locations Job Description- Computer System Validation (CSV) (Pharma ) Job Specifications • Specific experience working in reputed pharmaceutical company • Require prior experience in creating Change Requests, Developing Validation Plan, test scripts, Summary Reports, Traceability Matrix and other validation project documents in the Pharmaceutical industry • Sound knowledge on regulatory compliance. One or more of the following areas: CAPA, 21 CFR Part 11, GAMP, GMP, GLP, GCP, GVP, GxP, IQ/OQ/PQ and Computer Systems Validation (CSV) • Experience working on applications related to Electronic Laboratory Notebook (ELN), CDS, LIMS, SDMS etc. related to Discovery and Drug Product Development areas • Create and execute validation test scripts and document test results in accordance with standards (Manually or in HP Quality Center). Review and evaluate validation assessments for application systems/projects. Job Responsibilities • Initiate, drive and support validation efforts and deliverables for systems used for Discovery/Instruments/Clinical/Pre-clinical with minimal oversight • Advise customer and TCS technical organization in validation specific questions • Review and evaluate validation assessments for application systems/projects • Ensures that validation project documentation is in compliance with company and legal policies and procedures • Prior Experience with validation of Discovery/Instruments/Clinical systems preferred • Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center) • File validation documentation, following Quality Assurance Library guidelines • Provide monthly reports on of validation activities in the organization to Validation SME and/or Manager Quote
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