Plant IT Head

We are seeking a seasoned IT professional to lead the plant's IT infrastructure, applications, and systems.

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

Key responsibilities include designing, implementing, and maintaining robust infrastructure & systems to support various internal functions like production, engineering, QC, and warehouse within the manufacturing facility.

This role requires close collaboration with cross-functional teams and HO departments for any systems issues, improvements, CAPAs, and new projects implementation.

The successful candidate will be responsible for ensuring all IT systems comply with industry regulations and standards, particularly those relevant to GxP standards.

Responsibilities:

• Design and Implement Infrastructure & Systems: Develop and implement robust infrastructure & systems to support internal functions such as production, engineering, QC, and warehouse.
• Oversee Server Installation and Management: Oversee the installation, configuration, and management of servers to ensure optimal performance for reliable operations.
• Network Management: Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
• Information Security: Ensure information security measures, including cyber security protocols and privacy security standards to protect sensitive data.
• Cross-Functional Collaboration: Collaborate with cross-functional teams and HO departments for any systems issues, improvements, CAPAs, and new projects implementation.
• Troubleshooting and Support: Diagnostics and resolve technical issues related to IT systems, providing timely support to minimize downtime.
• Data Backup and Recovery: Handle data backup of all critical systems and conversant with online backup systems like Veeam and Acronics.
• Audit Compliance: Familiar with major audits like US FDA, MHRA, TGA, and relevant guidelines and compliance standards.
• cGAMP and Compliance Requirements: Good knowledge on cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11.
• System Assessment and Gap Analysis: Able to assess system gaps applicable to user management, data backup, systems hardware, software, and implement corrective actions.
• L1 Systems Upgradation and L2 Integration: 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.
• Quality Management Systems: Knowledge on quality management systems, change controls, incidents & deviations handling, RA & CAPA is a must.
• Industry 4.0 Strategies: Awareness on Industry 4.0 strategies and Smart Mfg initiatives will be an advantage.

About You:

• Proven track record of heading IT systems in medium to large-scale formulations or API manufacturing facilities.
• Familiarity with major audits like US FDA, MHRA, TGA, and relevant guidelines and compliance standards.
• Knowledge on cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11.
• Able to assess system 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.
• Familiarity with OTIT integration technologies like Kepware Gateway for PLC & IPC integration with central DAS systems.
• Knowledge on quality management systems, change controls, incidents & deviations handling, RA & CAPA.
• Awareness on Industry 4.0 strategies and Smart Mfg initiatives.

This role offers a challenging opportunity to work in a dynamic environment and contribute to the success of the organization.