IT Infrastructure Specialist

6 days ago

Surat, Gujarat, India beBeeInfrastructure Full time ₹ 4,50,00,000
Job Title: IT Plant Head

The position of IT Plant Head is a pivotal role within the Plant IT team. The successful candidate will be responsible for overseeing the overall IT infrastructure, applications, and systems that support plant operations.

  • This role involves heading the site IT team for routine tasks, working closely with cross-functional teams and HO departments to implement systems improvements, CAPAs, and digital projects.
  • Evaluate and upgrade existing IT infra systems, applications, and OT technologies to meet technology transformations and compliance requirements.
  • Support regulatory audits and extend assistance on various audit remediation tasks.

Key Responsibilities:

  • Design, implement, and maintain robust infrastructure and systems to support internal functions like production, engineering, quality control, and warehouse operations.
  • Oversee server installation, configuration, and management to ensure optimal performance.
  • Manage active and passive networking components including switches, routers, firewalls, and cable systems.
  • Understand pharmaceutical processes and their impact on product quality and safety.
  • Ensure IT systems comply with industry regulations and standards, particularly those relevant to GxP standards.
  • Maintain good documentation practices for IT infrastructure, applications, configurations, and procedures.
  • Implement information security measures, including cyber security protocols and privacy security standards, to protect sensitive data.
  • Collaborate with cross-functional teams and HO departments to resolve systems issues, improve systems, and implement new projects.
  • Diagnose and resolve technical issues related to IT systems, providing timely support to minimize downtime.
  • Manage data backup of all critical systems, working with online backup systems like Veeam and Acronics.
  • Familiarity with major audits like US FDA, MHRA, TGA, and relevant guidelines and compliance standards.
  • Knowledge of cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11.
  • Audit system gaps applicable to user management, data backup, hardware, software, and implement corrective actions.
  • Exposure to L1 systems upgrades and L2 integration, such as DAS/Historian.
  • Familiarity with OT-IT integration technologies, including Kepware Gateway for PLC and IPC integration with central DAS systems.
  • Understanding of quality management systems, with expertise in change controls, incidents, deviations handling, RA, and CAPA.
  • Awareness of industry 4.0 strategies and smart manufacturing initiatives is beneficial.

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