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Kashiv US

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Senior Officer, IT User Support

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Description

Key Responsibilities

  • Manage and maintain the organization's IT infrastructure, including servers, network systems, end-user devices, and associated applications.
  • Provide troubleshooting and technical support for all IT-related issues across the organization.
  • Install, configure, and maintain computers, laptops, software applications, printers, and peripheral devices.
  • Administer user accounts and access management activities, including creation, modification, deactivation, and deletion of user IDs for GxP and non-GxP computerized systems as per approved procedures.
  • Administer, monitor, maintain, and provide technical support for Quality Control Computerized Systems (QCC) and Manufacturing Computerized Systems, ensuring compliance with approved SOPs and applicable regulatory requirements.
  • Manage and maintain servers, laboratory systems, instruments, IPCs, SCADA systems, manufacturing systems, access control systems, and other computerized systems as per approved procedures.
  • Perform backup and restore activities for computerized systems according to approved schedules and procedures.
  • Perform time synchronization activities for GxP computerized systems as per approved schedules.
  • Prepare, review, and maintain active user lists and other system administration records as per approved procedures.
  • Actively participate in implementation, qualification, enhancement, validation, and maintenance of IT projects and computerized systems.
  • Initiate and support Change Controls, Deviations, CAPAs, Risk Assessments, and preparation or revision of SOPs and related documentation.
  • Maintain IT asset inventory records and ensure proper identification, labelling, issuance, retrieval, and reconciliation of IT assets.
  • Ensure return of all IT assets during employee separation and support clearance processes.
  • Troubleshoot and resolve printer-related issues and provide end-user support for associated systems.
  • Coordinate with cross-functional departments and external vendors for issue resolution, project execution, and system support activities.
  • Manage and maintain CCTV, EPABX, Access Control Systems, and related security systems.
  • Generate reports and maintain records related to access control, system administration, backups, and IT operations as required.
  • Prepare departmental plans, schedules, training matrices, and cGMP planners as applicable.
  • Support training management activities, including training assignment, functional mapping, compliance monitoring, and effectiveness verification.
  • Ensure compliance with cGMP, Data Integrity, Information Security, ALCOA+ principles, and applicable regulatory requirements.
  • Maintain accurate, complete, and contemporaneous records of all assigned activities.
  • Support internal audits, external audits, customer audits, and regulatory inspections.
  • Act as backup for departmental activities and support business continuity requirements.
  • Perform any other duties assigned by the Reporting Manager, Department Head, or Management.

Education:
  • Bachelors Degree (BA/BS) B.Tech - Required
  • Master Degree (MS/MA) M.Tech - Preferred
Experience:
  • 1 year or more in 1 - 4 Years
Specialized Knowledge: Licenses:

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