IT Plant Head

Job Title: Plant IT Head (Leading Pharma MNC)

Experience: 15 plus years

Location: Daman

Type: Full-time

Experience Level: [Senior]

Department: Formulations & API Manufacturing Plant

Salary: 45 Lakhs

Purpose of this Role

This Job Role will be a part of Plant IT and Responsible for Heading the overall IT Infra, Applications & Systems for the Plant Operations. 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 that includes Production, QC, Engg & Warehouse. Etc. This role shall lead the site IT team for routine tasks, closely work with Cross functional teams and HO Teams for any Systems improvements, CAPAs and lead Digital & Automation projects implementation at site. The Responsibility also includes 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). This Role will also play a vital position during Regulatory Audits and shall extend support on various Audit remediation tasks.

Job Description & Key Responsibilities:
• The ideal candidate shall have proven track record of Heading IT Systems in a Medium to Large scale Formulations or API Manufacturing Facility.
• Candidate shall able to Design, Implement, and maintain robust Infrastructure & Systems to support Various Internal functions like Production, Engg, QC & Warehouse…etc within the Manufacturing Facility.
• Oversee the installation, configuration, and management of servers, ensuring optimal performance for reliable operations.
• Shall be able to Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
• Shall be able to 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.
• Shall able to 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 and shall be able to do RCA for any specified issues.
• Handle data Backup of all critical systems and conversant with online backup systems like Veeam and Acronics.
• Should have experienced Major Audits like US FDA, MHRA, TGA…etc and familiar with relevant guidelines and Compliance standards.
• Good knowledge on 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.
• Good Exposure on L1 systems upgradation and L2 Integration like DAS/Historian. Shall be 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 is a must.
• Awareness on Industry 4.0 Strategies and Smart Mfg initiatives will be an advantage.
• Should be able to handle Annual IT Budgets for Operations and CAPEX for projects.

Technical & Preferred Skills:
• Proficiency in server management (Windows, Linux…etc.).
• 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 on 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.

Educational Qualification: B. Tech/B. E/B.Sc./BCA or above from a Reputed Institute. Experience: 15 to 20 Years of Relevant Experience: