Leading Plant Information Technology

4 days ago

Meerut, Uttar Pradesh, India beBeeInformationSecurity Full time ₹ 40,00,000 - ₹ 45,00,000

IT Operations Leader Job

As an IT Operations Leader, you will be responsible for the overall management of the IT infrastructure and systems within the manufacturing facility.

Key Responsibilities:

  • Design, implement, and maintain robust infrastructure and systems to support various internal functions like production, engineering, quality control, and warehouse operations.
  • Oversee the installation, configuration, and management of servers to ensure optimal performance and reliable operations.
  • 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 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 systems issues, improvements, CAPAs, and new projects implementation for a unified workflow.
  • Diagnose and resolve technical issues related to IT systems, providing timely support to minimize downtime, and conduct root cause analysis for specified issues.
  • Handle data backup of all critical systems and have experience with online backup systems like Veeam and Acronis.
  • Should have experience with major audits like US FDA, MHRA, TGA, etc., and be familiar with relevant guidelines and compliance standards.
  • Have good knowledge of cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11, etc.
  • Should be able to assess systems gaps applicable to user management, data backup, systems hardware, software, and implement corrective actions.
  • Have good exposure to L1 systems upgrades and L2 integrations like DAS/Historian.
  • Be familiar with OT-IT integration technologies like Kepware Gateway for PLC & IPC integration with central DAS systems.
  • Have knowledge on quality management systems with very good exposure into change controls, incidents, and deviations handling, RA & CAPA is a must.
  • Awareness on Industry 4.0 strategies and Smart Manufacturing initiatives will be an advantage.
  • Should be able to handle annual IT budgets for operations and CAPEX for projects.

Required Skills and Qualifications:

  • Proficiency in server management (Windows, Linux, etc.).
  • Strong knowledge of active and passive networking (LAN/WAN, switches, routers, firewalls).
  • Expertise in information security, cybersecurity, and privacy security.
  • Knowledge in pharmaceutical manufacturing and quality processes.
  • Adequate knowledge of OT-IT systems integration (L1 & L2 systems, DAS, Historian).
  • Exposure to various IT applications like SAP, eBMR, MES, QMS, LIMS, etc.
  • Ability to work in a cross-functional and challenging environment.
  • Capable of idea generation and process improvement skills.
  • Exposure to regulated audits like US FDA, MHRA, etc.
  • Certifications such as CISSP, CISM, CCNA, or equivalent are desirable.
  • Experience with cloud infrastructure (AWS, Azure, etc.).
  • Knowledge of virtualization technologies (VMware, Hyper-V, etc.).
  • Good project management and exposure to Computerized Systems Validation.

Benefits:

The ideal candidate will have a proven track record of heading IT systems in a medium to large-scale formulations or API manufacturing facility.

Others:

Bachelor's degree in a relevant field or above from a reputable institute.

15 to 20 years of relevant experience.

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