Walk-in || IT Head

JOB POSTING: Head Information Technology (Site IT & Computerised Systems Compliance)

Job Details

• Location: Pharmaceutical Manufacturing Plant (OSD / Injectables / API)
• Department: Information Technology
• Role Level: Senior Manager / AGM / DGM
• Reporting Line: Solid line to Plant Head / Site Director; Dotted line to Corporate CIO
• Functional Alignment: Head – Quality Assurance (GxP Computerised System Governance)
• Team Size: 6–20 personnel across Infrastructure, Applications, CSV, OT/Automation Support, and Helpdesk
• Employment Type: Full-time, Permanent

Job Purpose To lead, manage, and govern all IT and OT systems across manufacturing, QC, and QA. Ensure comprehensive infrastructure reliability, robust cybersecurity, and strict adherence to 21 CFR Part 11, EU GMP Annex 11, and Data Integrity (ALCOA+) principles throughout the complete system life cycle. Front-face regulatory inspections (USFDA, EU, MHRA, WHO, CDSCO) as the primary IT/CSV subject matter expert.

Key Responsibilities

1. Computerised System Validation (CSV / CSA)

• Maintain the Site Validation Master Plan (VMP) and keep the GxP system inventory current, including risk categorization and GAMP classification.
• Lead risk-based validation across the system life cycle: URS, vendor qualification, FDS/DDS, risk assessments, IQ/OQ/PQ, CSA-style assurance, RTM, and VSR.
• Apply GAMP 5 (2nd Edition) critical-thinking principles; scale validation effort according to patient safety, product quality, and data integrity risk.
• Conduct periodic reviews of validated systems, manage re-validation post-major changes, and oversee compliant decommissioning/archiving.

1. Data Integrity & Regulatory Technical Controls

• Enforce strict logical access controls across all GxP systems: unique user credentials, role-based access, password complexity, automatic session timeouts, and lockout policies (zero generic/shared accounts).
• Implement, maintain, and verify secure, time-stamped, non-editable audit trails synchronized with reliable network time protocols (NTP).
• Ensure compliant electronic signatures with signee name, timestamp, and meaning permanently linked to records.
• Partner with QA on risk-based audit trail review workflows and administer privileged user accounts independently of regular users.
• Drive remediation of data integrity risks: eliminate local PC storage, unsecured USB use, unvalidated spreadsheets, orphan files, and uncontrolled deletions.

1. Backup, Disaster Recovery & Business Continuity

• Manage automated, verified backup routines for all GxP and QC/manufacturing applications, ensuring regular documented restore tests.
• Maintain validated long-term electronic archives ensuring data and metadata readability across statutory retention periods.
• Own and execute the IT Disaster Recovery (DR) and Business Continuity Plan (BCP); conduct annual DR drills meeting defined RTO and RPO targets.

1. IT Infrastructure & Service Operations

• Oversee on-premises and private/hybrid cloud infrastructure: servers, SAN/NAS storage, virtualization (VMware/Hyper-V), structured cabling, and enterprise data center facilities (power, HVAC, fire suppression).
• Ensure formal qualification of underlying IT infrastructure supporting GxP applications.
• Run ITIL-aligned service management covering incident, problem, change, release, and configuration management.

1. OT, Manufacturing & Laboratory Systems Integration

• Support shop-floor automation systems (PLC/SCADA/HMI, DCS, BMS/EMS, and packaging line controllers) in close partnership with Engineering.
• Network QC instruments and systems (CDS like Empower/Chromeleon, LIMS) to enterprise infrastructure to remove standalone data silos.
• Implement Purdue Model / ISA-IEC 62443 network segmentation (zones and conduits) and enforce secure remote vendor access.

1. Cybersecurity & Information Security

• Enforce site-wide cybersecurity governance aligned with ISO 27001 and NIST CSF frameworks.
• Oversee vulnerability management, endpoint detection and response (EDR), firewall administration, SIEM, MFA, and regular patching via validated change controls.
• Direct cyber incident response, ensuring prompt regulatory notification (e.g., CERT-In within mandated timelines).
• Ensure organizational alignment with the Digital Personal Data Protection (DPDP) Act.

1. QMS Compliance & Audit Facing

• Author and maintain site IT SOPs (access control, backup/restore, change management, periodic review, DR, spreadsheet validation).
• Investigate IT deviations, raise CAPAs, and manage technical change controls within the site Quality Management System.
• Serve as the front-line IT/CSV lead during USFDA, EU/EMA, MHRA, WHO, CDSCO, and client audits; present validation files, access controls, audit trail configurations, and live system demonstrations.

1. Vendor Management & Strategic Projects

• Qualify IT vendors and software providers via audits, technical questionnaires, quality agreements, and SLAs.
• Direct digital transformation initiatives: ERP (SAP S/4HANA), MES / Electronic Batch Records (eBR), LIMS, eQMS, DMS, and serialization / track-and-trace.
• Own and control the site IT CAPEX and OPEX budgets.

Key Performance Indicators (KPIs)

• Critical/major regulatory observations on IT/CSV/Data Integrity: 0
• GxP systems with active validation status and periodic review: 100%
• Standalone instrument PCs migrated to central/network storage: 100%
• GxP backup success rate: >= 99.5% with 100% scheduled restore tests executed
• Critical application uptime (ERP, MES, CDS, LIMS): >= 99.5%
• Revocation of exiting personnel access: Within 24 hours
• Closure of IT deviations and CAPAs within target deadlines: >= 95%
• High-severity cyber breaches: 0

Candidate Profile

Education:

• Essential: B.E. / B.Tech in Computer Science, Information Technology, Electronics, or MCA / M.Sc. (IT/CS).
• Desirable: MBA (IT/Operations) or postgraduate qualification in Pharmaceutical Quality / Regulatory Affairs.

Experience:

• 15 to 20 years of core IT experience, with at least 8+ years in pharmaceutical, biotech, or API manufacturing plants.
• Minimum 5 years of experience heading site IT operations at a USFDA or EU-inspected facility.
• Deep hands-on experience in CSV/CSA of CDS (Empower/Chromeleon), LIMS, eQMS, SAP/ERP, and MES.
• Proven track record of independently defending computerised systems during regulatory inspections and resolving audit/483 observations.
• Strong grounding in OT networks, SCADA integration, and instrument interfacing.

Desirable Certifications:

• ISPE GAMP 5 / Computer System Validation / Data Integrity
• ITIL 4 Foundation / PMP / PRINCE2
• ISO/IEC 27001 Lead Auditor/Implementer, CISSP, or CISM
• ISA/IEC 62443 Cybersecurity
• OEM Certifications: Microsoft, VMware, Cisco, SAP Basis

Key Skills & Competencies

• Regulations: 21 CFR Part 11, 21 CFR 210/211, EU GMP Annex 11, PIC/S PI 041-1, WHO TRS 1033, Revised Schedule M, ICH Q9/Q10.
• Validation: GAMP 5 (2nd Ed.), Computer Software Assurance (CSA), Risk-Based Verification, URS/IQ/OQ/PQ, RTM.
• Systems: SAP S/4HANA, MES, LIMS, Waters Empower, Chromeleon, TrackWise/eQMS, SCADA, BMS.
• Infrastructure & Security: Active Directory, VMware, Firewalls, OT Network Segmentation, Disaster Recovery, Backup Solutions, ISO 27001, CERT-In compliance.