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High Salary! Computer system Validation

High Salary! Computer system Validation

Veeda LifesciencesIndia
3 hours ago
Job description

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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    Computer System Validation • India

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