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