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Computer system Validation [15h Left]
Veeda LifesciencesIndia11 hours ago
Job descriptionTo responsible for archive logbooks, forms, format, PTR Active participation during preparation requested from other department stack holder like arrangement of System with data restoration during sponsor and regulatory audits. 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
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 :
Audits & Regulatory compliance :
Others :
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Computer System Validation • India
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