Computer System Validation

3 weeks ago


Odhav, India Veeda Lifesciences Full time

Primary Responsibility: - To provide support for Bioanalytical systems and users. - Actively support participation in System /Software validation activity and its execution. - Responsible for IT Server and System Backup and restoration process as defined in Sops, must have knowledge documenting the activity as per above mentioned. - Weekly ,Monthly ,Yearly backup and integrity verification. - Should have worked as in lead role for team Management. - IT Incident management and response management with Quality assurance and other department stack holder in co-ordination with Vendors. - To review IT Sops for any update, amendment and revision if required and send applicable department for review & comments. - To initiate change control procedure for any changes (Hardware, software or any update in Sops), deviation procedure if any deviate the process, CAPA.Training & Archival: - To responsible for archive logbooks, forms, format, PTRAudits & Regulatory compliance: - Active participation during preparation requested from other department stack holder like arrangement of System with data restoration during sponsor and regulatory audits.Others: - Experience/ exposure US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5 Guidelines - Good communication and technical writing skills are a must. - 2-5 Years experience in Pharma or CRO will be added advantage



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