Hiring For IT Plant Lead

Hiring for IT Plant Lead

Key Responsibilities

• QMS Oversight & Compliance

• Manage and oversee QMS activities, including Corrective and Preventive Actions (CAPA), Deviations, and Change Control Forms (CCF).
• Initiate, track, and close CAPA, deviations, and CCFs within defined timelines to ensure compliance.
• Monitor effectiveness checks for CAPA and change controls, ensuring timely closure.

• Documentation & Systems Management

• Effectively manage and utilize QMS and DMS systems for documentation, reporting, and analysis.
• Coordinate preparation, review, and approval of Standard Operating Procedures (SOPs) across all sites.
• Ensure SOPs are updated, effective, and aligned with regulatory expectations.

• User & Shop Floor Management

• Manage production shop floor user creation, access rights, and controls in compliance with data integrity requirements.
• Oversee QCC (Quality Control Circle) activities and promote structured problem-solving initiatives on the production floor.
• Ensure production systems are aligned with QMS requirements, including access management, audit trails, and compliance monitoring.

• IT Infrastructure Support (up to L2 level)

• Provide end-user and system support up to Level 2 for hardware, software, and networking issues.
• Manage user account administration, application access, and security controls.
• Support backup solutions, data retention, and restoration processes for compliance and business continuity.
• Manage and support virtualization platforms (VMware/Hyper-V or equivalent) for system efficiency and availability.
• Provide operational support in networking, including LAN, WAN, firewalls, and secure connectivity across sites.
• Support cloud computing environments (AWS, Azure, or equivalent), ensuring compliance with data integrity and GxP guidelines.
• Assist in strengthening cybersecurity measures, including endpoint security, access controls, monitoring, and incident management.
• Coordinate with corporate IT teams for infrastructure upgrades, patch management, and system validations.
• Strong technical understanding of IT infrastructure (L1 & L2), including networking, backup, cloud, and cybersecurity.
• Ability to balance compliance, operational needs, and IT security effectively.

• Audit & Regulatory Support

• Ensure adherence to cGMP, USFDA, EMA, MHRA, and other global regulatory requirements.
• Provide support during internal/external audits and regulatory inspections.
• Maintain audit readiness by ensuring system documentation, user logs, and IT controls are compliant.

• Cross-functional Collaboration & Improvements

• Work closely with QA, Production, QC, Engineering, and IT teams to resolve system and compliance issues.
• Drive continuous improvement initiatives in QMS, IT infrastructure, and shop floor systems.
• Conduct training for plant teams on QMS, IT security awareness, and compliance Key Competencies