csv-it

2 weeks ago

Ahmedabad, Gujarat, India Veeda CR Full time ₹ 2,00,000 - ₹ 6,00,000 per year

JD Description For Junior ICT Administrator

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.
  • Experience in Pharma or CRO will be added advantage

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