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CSV Validation Analyst


JyothiK

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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

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