Job Title

Position Overview :- Strategic and hands-on IT leader responsible for managing multi-site GxP-compliant IT operations, plant infrastructure in a regulated pharmaceutical environment. Acts as the SPOC for IT for site leadership, ensuring uptime, compliance, and driving impactful technology-led business enablement. Experience 9-14 Years in Pharma Plant IT Operations with audit exposure.Qualification B.E. / B.Tech / BCA / BCS or an equivalent qualification, combined with relevant pharma IT experience and skillsetRESPONSIBILITIESGxP IT Operations & Compliance Ensure 100% uptime of GxP-critical systems and infrastructure. Maintain real-time audit readiness across all sites, manage SOP adherence, QMS notifications, CAPA closure, and periodic reviews. Enforce regulatory-compliant practices for user access control, data integrity, and electronicrecords. Collaborate with central SAP teams to align plant needs. IT Infrastructure & Security Management Oversee standardization, qualification, AMC, retirement, and reusability of IT assets. Implement robust IT security controls, patch management, and cybersecurity governance for both GxP and Non-GxP environments. Proactively identify and eliminate CSV bottlenecks affecting manufacturing continuity. Audit & Regulatory Readiness Act as audit-facing SPOC for IT during internal and external audits (MHRA, USFDA, WHO, etc.) as needed. Guide and mentor Site IT Leads to take SPOC responsibility at their respective sites, ensuring readiness and compliance. Lead pre-audit checks, documentation reviews, and post-audit CAPA implementation. Ensure full alignment of IT practices with 21 CFR Part 11, EU Annex 11, and data integrity guidelines. Project Delivery & Solution Implementation Lead IT solution implementation at plant level including POC, vendor coordination, and validation. Ensure IT GxP assets and integrations are CSV-validated and fully compliant with GxP requirements across all sites. Drive digital transformation and automation initiatives in quality and manufacturing. Team Leadership & Stakeholder Engagement Lead, coach, and upskill a 25+ member IT team (direct/indirect, L2 structure). Collaborate with cross-functional teams-Quality, Manufacturing, Engineering, and Projects. Conduct regular site leadership connects to align IT strategy with plant KPIs. IT Governance & AIOps Implement AIOps and predictive monitoring to enhance system reliability and automation. Define and track IT SLAs, KPIs, and compliance scorecards. Drive innovation while ensuring adherence to Unichem and IT Security / InfoSec standards. Value Addition: Proven success in enabling business continuity and audit compliance through IT solutions. Spearheaded SAP-integrated projects and AIOps implementation, reducing downtime and manual interventions. Delivered cross-site standardization of IT operations, ensuring cost savings and audit consistency.DESIRED SKILLS Deep knowledge of Pharma IT Compliance (GxP, CSV), plant automation systems, and IT infrastructure lifecycle. Extensive experience in managing GxP-compliant IT operations at manufacturing sites, with deep understanding of the computerized system validation (CSV) lifecycle and regulatory requirements. Excellent leadership, audit-facing, communication, and cross-functional stakeholder management skills. SAP certification & relevant IT certifications preferred. Strong technical knowledge of SAP systems and IT infrastructure components (networking & server administration). Experience in SAP HANA, SAP Fiori, or a similar technology is a plus. Excellent problem-solving, analytical, and troubleshooting skills. Strong attention to detail with a proactive approach to solving complex technical problems. Should have project management experience and familiarity with project management methodologies (Agile, Waterfall, etc.). Familiarity with security frameworks and best practices in both SAP and IT infrastructure management. Knowledge of system integration techniques between SAP and IT infrastructure. Strong communication skills and the ability to interact effectively with technical and non-technical stakeholders. Strong leadership and interpersonal skills, with the ability to motivate and manage a multidisciplinary team. Willingness to work on diverse projects / areas. Strategic thinker with a focus on both operational efficiency and business alignment. Strong understanding of cybersecurity principles in plant IT environments, with hands-on experience in monitoring, detecting, and responding to threats to ensure protection against potential cyberattacks. Ability to implement and maintain robust security controls for both IT and OT assets in compliance with regulatory and InfoSec standards.