IT Operations Manager

3 days ago

Kottayam, Kerala, India beBeeOperations Full time ₹ 40,00,000 - ₹ 45,00,000

Job Title: IT Operations Manager

Overview

This role is part of Plant IT and involves heading the overall IT Infrastructure, Applications & Systems for Plant Operations. Key Responsibilities:

  • Support, Maintain and Enhance IT Operations required to meet Manufacturing and Compliance necessities of Plant operations that includes Production, QC, Engg & Warehouse.
  • Closely work with Cross functional teams and HO Teams for any Systems improvements, CAPAs and lead Digital & Automation projects implementation at site.
  • Evaluation and upgradation of Existing IT Infra Systems, Applications and OT Technologies to meet Technology Transformations and enhanced Compliance requirements as per Regulatory Guidelines (USFDA, EU-FMD etc).
Key Skills and Qualifications
  • Heading IT Systems in a Medium to Large scale Formulations or API Manufacturing Facility.
  • Design, Implement, and maintain robust Infrastructure & Systems to support Various Internal functions like Production, Engg, QC & Warehouse…etc within the Manufacturing Facility.
  • Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
  • Understand Pharmaceutical Processes and its importance on Product Quality & Safety.
  • Ensure all IT systems complies 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 cyber security protocols and privacy security standards to protect sensitive data.
  • Collaborate with Cross Function Teams and HO departments for any systems issues, improvements, CAPAs and New projects implementation for a unified work flow.
  • Diagnose and resolve technical issues related to IT Systems providing timely support to minimize downtime.
  • Handle data Backup of all critical systems and conversant with online backup systems like Veeam and Acronics.
  • Familiar with Major Audits like US FDA, MHRA, TGA…etc and relevant guidelines and Compliance standards.
  • Knowledge on cGAMP and Compliance requirements like 21 CFR Part 11 and EU-Annexure 11.etc.
  • Able to assess Systems gaps applicable to User Management, Data Backup, Systems Hardware, Software and implement corrective actions.
  • Exposure on L1 systems upgradation and L2 Integration like DAS/Historian.
  • Familiar with OTIT Integration Technologies like Kepware Gateway for PLC & IPC Integration with Central DAS systems.
  • Knowledge on Quality management Systems with very good exposure into change controls, Incidents & Deviations handling, RA & CAPA.
  • Awareness on Industry 4.0 Strategies and Smart Mfg initiatives.
Benefits
  • The successful candidate will have opportunity to work on various Digital & Automation projects.
  • Will be involved in evaluation and upgradation of Existing IT Infra Systems, Applications and OT Technologies.
  • Will be responsible for ensuring all IT systems complies with Industry regulations and standards.

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