Job Title: Sr. Manager - IT Infrastructure
Purpose of Job
Responsible for managing the SEZ Site IT Infrastructure including servers, network, helpdesk, GxP IT activities as per SOPs, QMS, etc. & operations governance, Stakeholder management and handling regulatory audits. This role ensures uninterrupted plant IT operations, strict regulatory compliance and adherence to data integrity principles while enabling technology-driven efficiency and business continuity.
Roles and Responsibilites
1. IT Infrastructure & Plant Operations
- Lead, Manage and maintain IT infrastructure for the SEZ Pharma manufacturing site, including servers(on premise and Azure Cloud hosted), database, networks, plant systems, emails, and data centres.
- Ensure 24x7 uptime for production-critical systems and Enterprise Systems such as MES/eBMR, SCADA, LIMS, Chromatographic systems like Chromeleon, PLC-connected machines, etc.
- Monitor system performance and ensure maximum uptime across all business functions.
- Ensures IT controls, user administration, system backups, data recovery, DR Drills, preventive maintenance, remote access, etc. are performed by Site IT team as per SOPs.
- Collaborate with cross-functional teams for OT system upgrades and digital transformation projects
- Ensure necessary IT support availability for reducing the GxP systems downtime and take proactive measures to minimize downtime.
- Implement and maintain hardware, software, and network upgrades.
- Manage and mentor L2/L3 system engineers, ensuring effective escalation handling and service delivery.
- Oversee Active Directory, Azure AD, GPO, and hybrid identity solutions.
- Plan, execute, and monitor IT projects, ensuring adherence to timelines, budgets, and quality standards.
- Optimize IT resources for performance, scalability, and cost-effectiveness.
- Reporting & Governance: Generate regular performance, compliance, and security reports for leadership.
- Collaboration & Stakeholder Engagement: Work with business leaders and global IT teams to align IT delivery with organizational needs.
2. Regulatory Compliance (GxP, 21 CFR Part 11, Data Integrity)
- Implement and maintain compliance with GMP/GxP guidelines such as 21 CFR Part 11, Annexure 11, and pharma data integrity ALCOA+ requirements for all computerized systems including servers and enterprise systems.
- Participate in periodic internal as well as regulatory audits, validation activities, IQ/OQ/PQ, Change
- Control/Change Request, CAPA, Deviation, Investigation, audit response, etc.
3. IT Security & Compliance
- Implement cybersecurity controls aligned with industry standards and companys IT Security policies to ensure protection of sensitive production, quality, and R&D data.
- Manage backup, Restoration, disaster recovery (DR), and business continuity planning (BCP) for the plant IT systems.
- Manage antivirus, patch management, access control, and IT security audits.
Relevant Skills & Experience:
1. Team Leadership & Vendor Coordination
- Lead the site-level IT team and ensure high-quality and timely user support.
- Manage AMC contracts, agreements, SLAs with IT vendors and service providers.
- Responsible for IT asset management, license renewals, and procurement.
2. IT Support & Helpdesk
- Lead the IT support team to deliver timely and effective user support for production, QA, QC, warehouse, engineering, and other departments.
- Maintain IT documentation, knowledge base, and SOPs for routine tasks.
- Oversee troubleshooting of hardware, software, plant equipment interfaces, and network issues with proper root cause and corrective/preventive actions.
- Training and Development of Site IT Team
3. IT Strategy & Continuous Improvement
- Participate in digital transformation initiatives, and automation upgrades.
- Participate in evaluation of emerging technologies relevant to pharma manufacturing.
4. IT Project Management
- Lead IT infrastructure and application projects.
- Participate in planning and executing rollouts, migrations, and technology upgrades.
- Coordinate with cross-functional teams to ensure timely project completion
Relevant professional / Educational background
- Bachelor’s degree in Information Technology, Computer Science, or related field.
- Experience in Pharma, Chemical or manufacturing organization
- 12 years of IT experience, with at least 7 to 18 years in a regulated manufacturing/ pharma environment.
- Minimum 7 years of experience as IT Team Lead of 10+ team size
- Candidate who has worked in remediated pharma plant will be given preference
SEZ, Ahmedabad, GJ, IN, 382213