Head of Plant Infrastructure

4 days ago

Kurnool, Andhra Pradesh, India beBeeCompliance Full time ₹ 40,00,000 - ₹ 45,00,000
Plant IT Head Role

This is a leadership position overseeing the overall IT infrastructure, applications, and systems for plant operations.

Key Responsibilities:

  • Ensure effective IT operations to meet manufacturing and compliance requirements of plant operations.
  • Lead the site IT team in routine tasks, collaborate with cross-functional teams and HO departments for system improvements and digital project implementations.
  • Evaluate and upgrade existing IT infrastructure systems, applications, and OT technologies to meet technology transformations and enhanced compliance requirements as per regulatory guidelines.
  • Provide critical support during regulatory audits and extend assistance on audit remediation tasks.

Requirements:

To be successful in this role, you should have a proven track record of heading IT systems in medium to large-scale formulations or API manufacturing facilities.

  • Ability to design and implement robust infrastructure and systems to support internal functions within the manufacturing facility.
  • Oversee the installation, configuration, and management of servers to ensure optimal performance.
  • Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
  • Ensure all IT systems comply with industry regulations and standards, particularly those relevant to GxP standards.
  • Maintain accurate 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 for system issues, improvements, CAPAs, and new project implementations.
  • Diagnose and resolve technical issues related to IT systems providing timely support to minimize downtime.
  • 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 systems gaps applicable to user management, data backup, systems hardware, software, and implement corrective actions.
  • Knowledge on L1 systems upgradation and L2 integration like DAS/Historian, OT-IT integration technologies like Kepware Gateway for PLC & IPC integration with central DAS systems.

Technical Skills:

  • Proficiency in server management (Windows, Linux).
  • Strong knowledge of active and passive networking (LAN/WAN, switches, routers, firewalls).
  • Expertise in information security, cyber security, and privacy security.
  • Knowledge in pharmaceutical manufacturing and quality process.
  • Adequate knowledge of OT-IT systems integration (L1 & L2 systems, DAS, Historian).
  • Exposure to various IT applications like SAP, eBMR, MES, QMS, LIMS.

Education and Experience:

Bachelor's degree in Computer Science or related field from a reputable institution.

At least 15 years of experience in IT management, preferably in a similar role.

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