Computer system Validation

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, PTR Audits & 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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