Subject: Application for Senior IT Leadership Position

IT Professional CV

Application for Senior IT Infrastructure Digital Transformation GxP Compliance Cybersecurity Leader 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 16+ years of experience in pharmaceutical and regulated manufacturing environments. Proven expertise in IT Operations, Infrastructure Management, GxP Compliance, Computer System Validation (CSV), Computer Software Assurance (CSA), Cybersecurity, Disaster Recovery, Business Continuity, and Regulatory Audit Readiness. Demonstrated success in leading enterprise IT operations across multi-site manufacturing facilities, ensuring high system availability, regulatory compliance, cybersecurity resilience, and operational excellence. Extensive experience in implementing and supporting SAP, LIMS, TrackWise QMS, Werum PAS-X, Serialization & Track-and- Trace Systems, Laboratory Informatics Platforms, and Industry 4.0 initiatives. Recognized for successfully supporting US FDA and global regulatory inspections, leading cyber incident recovery, driving digital transformation programs, strengthening IT governance, and aligning technology strategy with business objectives.

KEY ACHIEVEMENTS:

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

Managed resolution activities during the global CrowdStrike outage, minimizing operational impact and ensuring service restoration.

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

Led implementation of enterprise solutions including SAP, Werum PAS-X eBR, TrackWise QMS, Serialization, QR Code Systems, E-Log, and Laboratory Informatics platforms.

Directed multi-site IT infrastructure operations, digital transformation initiatives, and GxP-compliant system management across regulated manufacturing facilities.

Received performance and recognition awards for operational excellence, compliance management, and customer support.

CORE COMPETENCIES:

IT Leadership

& Operations:

Compliance

& Quality:

Cybersecurity

& Business

Continuity:

Infrastructure

& Technology:

Management:

IT Infrastructure

Management

GxP Compliance

Cybersecurity &

IT/OT Security

VMware

Administration

CAPEX/OPEX

Budgeting

IT Operations

Leadership

Computer System

Validation (CSV)

Disaster Recovery

Planning

Windows Server

Administration

Vendor

Management

IT Governance Computer

Software

Assurance (CSA)

Business

Continuity

Management

Active Directory

Microsoft 365

Contract & SLA

Management

IT Service

Management

(ITSM)

FDA / MHRA

Audit Readiness

Risk Assessment &

Mitigation

Backup & Storage

Solutions

Procurement &

Asset Management

Team Leadership

& Mentoring

Data Integrity Security Hardening

Network & Firewall

Administration

Stakeholder

Management

SOP Development

& Compliance

Vulnerability &

Patch Management

Data Center

Management

ENTERPRISE APPLICATIONS:

Business & Quality

Systems

Manufacturing Systems Laboratory Systems Automation & Industry 4.0

SAP TrackWise QMS

ValGenesis VLMS

ComplianceWire LMS

SharePoint DMS

Werum PAS-X Syncade

eBMR Leucine eLog

Serialization & Track-and-

Trace QR Code Systems

LIMS Empower

Chromeleon Lab

Solutions

PLC/SCADA Integration

IT/OT Integration Early

Warning System (EY)

Paperless Manufacturing

PROFESSIONAL EXPERIENCE:

Senior Technical Lead – Infrastructure (Cluster Lead) Strides Pharma Science Ltd. (Through Coforge Ltd.) Bengaluru Oct 2025 – Present Key Responsibilities

Lead IT infrastructure operations across manufacturing sites ensuring business continuity, availability, security, and regulatory compliance.

Manage servers, storage, backup systems, virtualization environments, and network infrastructure.

Oversee GxP-compliant systems including user access governance, audit trails, backup verification, and data integrity controls.

Lead IT projects, digital transformation initiatives, and compliance-related activities.

Manage ITSM operations and SLA performance.

Coordinate site and corporate review meetings, Quality Review Board discussions, and compliance activities.

Provide technical leadership and mentorship to infrastructure and support teams. Key Achievement

Successfully supported an unannounced US FDA inspection (May 2026) with strong IT compliance readiness.

Applications

ValGenesis VLMS, ComplianceWire LMS, TrackWise QMS, Syncade eBMR, SAP, Leucine eLog, SharePoint, Microsoft 365, IBPS DMS, IT/OT Integration Platforms.

Manager – IT (Unit Lead)

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

Managed IT operations for multiple pharmaceutical manufacturing facilities.

Ensured GxP compliance and infrastructure availability.

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 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, backups, and cybersecurity programs.

Strengthened business continuity and disaster recovery capabilities.

Managed vendor contracts, software licensing, 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 resolved the global CrowdStrike outage impact during July 2024.

Implemented QR Code systems, Empower, Medhas, CCTV, LAPS, Ignio, and Electronic Logbook solutions. Continuous Improvement

Active participant in Kaizen, IFQM, Quality Circle, Gemba Walks, and Operational Excellence initiatives. Assistant Manager – IT (Department Head)

Ajanta Pharma Ltd. Bharuch Nov 2021 – Sep 2022 Responsibilities

Managed IT infrastructure, firewall administration, 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 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 validation deliverables including URS, Risk Assessments, GAP Analysis, FAT, IQ/OQ/PQ documentation, and SOPs.

Administered user account management, audit trails, electronic records, backup verification, and data integrity controls.

Major Projects

IT/OT Network integration PLC/SCADA Integration Track & Trace Solution (ACG & Rfxcel)

Chromeleon Upgrade, Empower Implementation & LabSolutions Deployment

Industry 4.0 Initiatives Paperless Manufacturing Program. Achievement

Successfully supported multiple 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. (Client: 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 third-party 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 Grade - A Grade IITMS (Imperial Institute of Technical & Management Studies) 2023 B. Com Class - Second Class Mumbai University 2011 H.S.C Class - Pass Class Pune University 2005 S.S.C Class - Second Class Cuttack University 2003 CERTIFICATIONS

Microsoft MCITP

Cisco CCNA

Red Hat System Administration

Computer System Validation (CSV)

Computer Software Assurance (CSA)

Hardware & Networking

LANGUAGES:

English Hindi Telugu Oriya Marathi Gujarati

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