Executive - IT CSV - 3635

Job Description

• Knowledge of IT Hardware/Network/Software Application components
• Sound knowledge of Data backup technologies & SQL Database
• Sound knowledge of Audit trail review of instrument/Equipment/Computerized systems
• Preparation & Perform validation documentation of PLC/SCADA, Computerized systems
• Sound knowledge of US FDA, 21 CFR Part 11, EU Annex 11 and GAMP5
• Sound knowledge of risk based approach of computerized systems
• Shall be able to prepare and review SOP related to computerized systems
• Knowledge of investigation of incidents of computerized systems
• Compliance of IT & across functional SOP (Backup, IT Inventory, User Management, Equipment Software, etc.)
• Documentation (change control, CAPA, Deviation, Breakdown (incident), On Job Training, Training need Identification, Issuance & Retrieval)
  

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