Subject: Application for Senior IT Leadership Position

IT Professional CV

Subject: Senior IT Leader IT Infrastructure & Operations Digital Transformation Cybersecurity GxP Compliance CSV/CSA Regulatory Audit Readiness IT Governance. NAGESWAR RAO

Email: ************@*****.*** Mob: +91-989**-***** 799**-***** LinkedIn: www.linkedin.com/in/nageswar-rao-pedini-9244b878 PROFESSIONAL SUMMARY:

Senior IT Infrastructure and Digital Transformation Leader with 15+ years of experience in pharmaceutical manufacturing, regulated environments, and enterprise IT operations. Proven expertise in IT Infrastructure Management, Cybersecurity, Computer System Validation (CSV), Computer Software Assurance (CSA), Disaster Recovery, Business Continuity, Data Integrity, and Regulatory Compliance. Demonstrated success in leading multi-site IT operations, managing enterprise infrastructure, driving digital transformation initiatives, and ensuring operational excellence within GxP-regulated environments. Extensive experience supporting SAP, Werum PAS-X, TrackWise, LIMS, Serialization and Track-and-Trace Systems, PLC/SCADA Integration, Laboratory Informatics Platforms, and Industry 4.0 initiatives. Recognized for successfully supporting US FDA, MHRA, WHO, and customer audits, leading cybersecurity recovery programs, strengthening IT governance frameworks, and aligning technology investments with business objectives.

KEY ACHIVEMENTNS:

Successfully led business continuity and recovery operations during a major cybersecurity incident in a pharmaceutical manufacturing environment.

Managed remediation and service restoration activities during the global CrowdStrike outage, minimizing business disruption and operational impact.

Supported multiple US FDA, MHRA, WHO, customer, and internal audits, including unannounced inspections, with strong compliance outcomes.

Led implementation of SAP, LIMS, Werum PAS-X eBR, Serialization and Track-and-Trace Systems, QR Code Solutions, Electronic Logbooks, and Laboratory Informatics Platforms.

Directed multi-site IT infrastructure operations and digital transformation initiatives across regulated pharmaceutical manufacturing facilities.

Received multiple awards and recognitions for operational excellence, compliance management, leadership, and customer support.

CONTINUOUS IMPROVEMENT:

Actively participated in IFQM, Quality Circles, Kaizen, Gemba Walks, and Operational Excellence initiatives, driving process improvements, compliance excellence, and cross-functional collaboration. CORE COMPETENCIES:

IT Leadership & Operations: IT Infrastructure Management IT Operations Leadership IT Governance IT Service Management (ITSM) Incident & Problem Management Team Leadership & Mentoring Stakeholder Management.

Compliance & Quality: GxP Compliance Computer System Validation (CSV) Computer Software Assurance

(CSA) FDA / MHRA Audit Readiness Data Integrity SOP Development & Compliance Risk Assessment & Mitigation.

Cybersecurity & Business Continuity: Cybersecurity & IT/OT Security Disaster Recovery Planning Business Continuity Management Security Hardening Vulnerability & Patch Management Backup & Recovery Management.

Infrastructure & Technology: Windows Server Administration VMware Administration Active Directory

Microsoft 365 Storage & Backup Solutions Network & Firewall Administration Data Center Management.

Management: CAPEX/OPEX Budgeting Vendor Management Contract & SLA Management Procurement & Asset Management Strategic Planning. ENTERPRISE APPLICATIONS:

Business & Quality Systems: SAP TrackWise QMS ValGenesis VLMS ComplianceWire LMS SharePoint DMS

Manufacturing Systems: Werum PAS-X Syncade eBMR Leucine eLog Serialization & Track-and-Trace

QR Code Systems.

Laboratory Systems: LIMS Empower Chromeleon Lab Solutions TOC-L Tiamo IR Systems

Automation & Industry 4.0: PLC/SCADA Integration IT/OT Integration Early Warning System (EWS)

Paperless Manufacturing.

PROFESSIONAL EXPERIENCE:

Sr. Technical Lead – Infrastructure (Cluster Lead) Strides Pharma Science Ltd. (via Coforge Ltd), Bengaluru Oct 2025 – Present Key Responsibilities

Directed multi-site IT infrastructure operations across pharmaceutical manufacturing facilities, ensuring regulatory compliance, cybersecurity resilience, business continuity, and high system availability.

Manage servers, storage, backup solutions, virtualization platforms, networks, firmware upgrades, patch management, and preventive maintenance activities.

Oversee IT budgeting, AMC renewals, software licensing, and asset procurement.

Drive IT strategy, risk management, compliance initiatives, and digital transformation programs.

Manage ITSM operations, QMS activities, periodic reviews, and SLA performance.

Ensure GxP compliance, user access governance, audit trail reviews, backup verification, and data integrity controls.

Participate in site and corporate review meetings, Quality Review Boards, and compliance discussions.

Mentor IT teams and cross-functional stakeholders to enhance compliance awareness and operational excellence.

IT Strategy & Roadmap Planning, IT Risk Management, Regulatory Inspection Readiness, Data Governance, IT Asset Lifecycle Management, Change Control Management, Vendor Risk Management, Operational Excellence, Manufacturing Systems Support.

Prepare and present weekly and monthly MIS reports to ensure transparency and performance tracking. Key Achievement

Successfully supported an unannounced US FDA inspection (May 2026) with strong IT compliance readiness and implemented Nagios monitoring and OT network enhancements for GxP manufacturing systems.

Applications Supported

Microsoft 365, SharePoint, ComplianceWire LMS, SAP, TrackWise QMS, Syncade eBMR, Leucine eLog, and ValGenesis VLMS.

Manager – IT (Unit Lead FTO-7 & 11)

Dr. Reddy’s Laboratories (Via Fidelis Pvt. Ltd.) Vizag Mar 2025 – Sep 2025

Managed IT operations across multiple pharmaceutical manufacturing facilities.

Ensured infrastructure availability, cybersecurity compliance, and GxP adherence.

Implemented corporate IT standards, SOPs, and governance frameworks.

Participated in leadership review meetings and Quality Review Board discussions.

Reviewed and approved GxP documentation through electronic quality management systems.

Manager – IT (Department Head)

Sun Pharma Laboratories Ltd. Guwahati Dec 2022 – Feb 2025 Key Responsibilities

Led complete IT operations for OSD and NOSD manufacturing facilities.

Managed data center operations, servers, storage, networking, backup, OS/firmware upgrades, patch management, preventive maintenance and cybersecurity programs.

Strengthened business continuity and disaster recovery capabilities.

Managed vendor contracts, software licensing renew, IT procurement, and annual IT budgets.

Led site-level digital transformation initiatives and enterprise application deployments. Major Achievements

Successfully led site recovery during the March 2023 cybersecurity incident.

Successfully managed global CrowdStrike outage remediation during July 2024.

Implemented digital platform, Medhas system for IT Assets & Inventory, Electronic Logbook solutions, QR Code system, Empower & LabSolutions upgradation, CCTV Integration, LAPS, Ignio, CrowdStrike, Deep security, Falcon Antivirus.

Continuous Improvement

Actively participated in Kaizen, IFQM, Quality Circles, Gemba Walks, and Operational Excellence initiatives.

Assistant Manager – IT (Department Head)

Ajanta Pharma Ltd. Bharuch Nov 2021 – Sep 2022 Responsibilities

Managed IT infrastructure, firewall, backup systems, NAS storage, manufacturing systems, and QC systems.

Controlled IT budgets, procurement processes, vendor management, and SAP-based purchasing activities. Projects

Werum PAS-X Electronic Batch Record (eBMR)

Early Warning System (EWS)

Achievement

Successfully supported US FDA, Zambia, and Kenya regulatory audits with zero critical IT observations.

Senior Executive – QA IT

Cadila Pharmaceuticals Ltd. Ahmedabad Aug 2019 – Nov 2021 Responsibilities

Served as SPOC for Computer System Validation (CSV) and IT Quality Assurance.

Prepared IT SOP’s, validation documents including URS, Risk Assessments, GAP Analysis and support internal program development team.

Managed user access controls, audit trails & electronic records, data backup verification, and data integrity controls.

Major Projects

IT/OT Integration, PLC/SCADA Integration, Industry 4.0 and Paperless Manufacturing Initiatives.

Track & Trace Solution upgradation (ACG & Rfxcel), Chromeleon, Empower & LabSolutions Upgradation. Achievement

Successfully supported FDA and international customer audits.

Executive – IT (Unit Lead)

Concord Biotech Ltd. Ahmedabad May 2018 – Jul 2019 Responsibilities

Managed complete site IT operations and compliance activities. Projects

ERP Progen, Track & Trace, Abacube Cloud

Achievement

Successfully supported FDA and customer audits with zero IT observations.

IT Operations Analyst (CSV & Site Lead)

Accenture Services Pvt. Ltd. (Zydus Cadila) Ahmedabad Dec 2015 – May 2018 Responsibilities

Managed IT infrastructure, data center operations, GxP compliance, backups, and CSV documentation.

Implemented IT governance frameworks and standardized operating procedures.

Administered user access, audit trails, and backup verification activities. Projects

Enterprise GSOP Rollout, Standardized IT Governance Across Manufacturing Sites. Achievements

Champion Trophy Award – Accenture

Silver Coin Recognition – Zydus Cadila

Supported multiple FDA and Customer audits successfully

System Administrator

Accel Frontline Ltd. (Client: Exim Bank) Mumbai Jul 2012 – Nov 2015 Responsibilities

Provided L2 support for enterprise users and infrastructure services.

Managed Active Directory, Exchange Server, backups, firewalls, and banking applications.

Supported Palo Alto, SonicWall, and Cisco security environments. Achievement

Received Best Performance Award – Mumbai Region. EDUCATION:

MBA A Grade Imperial Institute of Technical & Management Studies (IITMS) 2023 Bachelor of Commerce (B. Com) Mumbai University 2011 PROFESSIONAL CERTIFICATIONS & TRAININGS:

Microsoft MCITP

Cisco CCNA

Red Hat System Administration

Computer System Validation (CSV)

Computer Software Assurance (CSA)

Hardware & Networking

LANGUAGES:

English Hindi Oriya Telugu Marathi Gujarati

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