Urgent! 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