IT Infrastructure Strategist

2 days ago

Coimbatore, Tamil Nadu, India beBeeItInfrastructure Full time ₹ 30,00,000 - ₹ 45,00,000
Job Title: IT Infrastructure Head

The ideal candidate will lead the overall IT infrastructure and systems for a manufacturing facility. The purpose of this role is to support, maintain and enhance IT operations required to meet the manufacturing and compliance necessities of the plant operations.

This role will be responsible for heading the site IT team for routine tasks, closely working with cross-functional teams and HO teams for any system improvements, CAPAs and leading digital and automation projects implementation at site.

The responsibility also includes evaluating and upgrading existing IT infra systems, applications and OT technologies to meet technology transformations and enhanced compliance requirements as per regulatory guidelines.

This role will also play a vital position during regulatory audits and shall extend support on various audit remediation tasks.

Key Responsibilities:
  • Design, implement, and maintain robust infrastructure and systems to support various internal functions like production, engineering, quality control, and warehouse within the manufacturing facility.
  • Oversee the installation, configuration, and management of servers, ensuring optimal performance for reliable operations.
  • Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
  • Understand pharmaceutical processes and its importance on product quality and safety.
  • Ensure all 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.
  • Ensure information security measures, including cybersecurity protocols and privacy security standards to protect sensitive data.
  • Collaborate with cross-functional teams and HO departments for any system issues, improvements, CAPAs, and new project implementations for a unified workflow.
  • Diagnose and resolve technical issues related to IT systems, providing timely support to minimize downtime, and perform root cause analysis for any specified issues.
  • Handle data backup of all critical systems and be conversant with online backup systems like Veeam and Acronics.
  • Familiarity with major audits like US FDA, MHRA, TGA, and relevant guidelines and compliance standards.
  • Good knowledge of cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11.
  • Assess system gaps applicable to user management, data backup, systems hardware, software, and implement corrective actions.
  • Good exposure to L1 system upgrades and L2 integrations like DAS/Historian.
  • Familiarity with OT-IT integration technologies like Kepware Gateway for PLC and IPC integration with central DAS systems.
  • Knowledge of quality management systems with good exposure into change controls, incidents, and deviations handling, RA and CAPA.
  • Awareness of Industry 4.0 strategies and smart manufacturing initiatives will be an advantage.

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