Cluster Lead _ Digital IT Operations_GxP Compliance _ Cyber Security

COVER LETTER

Subject: Application for Digital IT Operations, GxP Compliance, Infrastructure Management & Cybersecurity (IT/OT), CSV and IT auditee role.

Dear Sir / Madam,

I am Nageswar Rao, an MBA in Information Technology and a Microsoft Certified Professional, with over 15 years of extensive experience in IT infrastructure management, digital IT operations, GxP compliance, cybersecurity (IT/OT), and Computer System Validation (CSV) within regulated pharmaceutical environments.

Currently, I am working as Cluster IT – Strides Pharma Science Ltd. (through Coforge Ltd.), Bengaluru, where I oversee end-to-end IT operations across manufacturing sites and lead strategic initiatives to strengthen operational resilience, regulatory compliance, and cybersecurity posture. Throughout my career, I have successfully managed IT operations in GMP-regulated manufacturing and laboratory environments, ensuring system reliability, data integrity, and compliance with global regulatory standards. My professional journey includes key roles at Strides Pharma Science Ltd., Dr. Reddy’s Laboratories, Sun Pharma, Ajanta Pharma, Cadila Pharmaceuticals, Concord Biotech, Zydus Cadila, and Accel Frontline. This breadth of exposure has equipped me with a strong blend of hands-on technical expertise and strategic leadership capabilities.

Key Areas of Expertise:

Digital IT Operations & Infrastructure Management: End-to-end management of data centers, servers, IT/OT networks, firewalls, end-user computing, IT assets, and enterprise platforms to ensure business continuity and operational excellence.

Cybersecurity & Risk Management (IT/OT): Proactive threat detection, vulnerability management, incident response, and forensic analysis across enterprise and manufacturing environments, ensuring secure and compliant operations.

Enterprise Applications & Automation: Deployment and support of Office 365, SAP, ERP (Progen), Pharmacovigilance systems, LIMS, Werum PAS-X EBR, QR code solutions, Track & Trace, and TrackWise, enabling digitization and automation.

GxP, CSV & Regulatory Compliance: Validation, change control, and lifecycle management of IT systems aligned with GMP, GLP, 21 CFR Part 11, FDA, WHO, MHRA, DCGI, and data integrity expectations.

Audit & Inspection Readiness: Hands-on experience supporting USFDA, WHO, MHRA, DCGI, and internal audits, including observation responses, CAPA management, SOP development, and evidence preparation.

I bring a strong foundation in Quality Management Systems (QMS) and compliance governance, with practical exposure to TrackWise, LIMS, eVAL, SAP, GSOPs, IT policy frameworks, self-inspections, and risk assessments. My ability to bridge technology execution with regulatory alignment has consistently strengthened audit readiness, minimized compliance risks, and improved operational efficiency. I am confident that my experience in digital IT operations, infrastructure management, cybersecurity, and GxP compliance will add measurable value to your organization. I would welcome the opportunity to further discuss how my background aligns with your requirements and how I can contribute to your team’s success. Thank you for your time and consideration.

Sincerely,

Nageswar Rao

RESUME

Microsoft Certified IT Professional, Cisco Certified Network Associate Computer System Validation Lifecycle and Compliance Training: CSV Training – Completed in May 2016, conducted by Epitome Technologies. Focused on validation lifecycle, GxP compliance, GDP, and documentation practices. CSA Conference - Attended the 2nd Annual Computer Software Assurance program in February 2022, conducted by EBM. Covered advanced approaches to CSA, risk-based validation, and regulatory expectations.

Address: Odisha

Cell: + (91-989******* 799**-*****

Email: ************@*****.***

CAREER OBJECTIVE:

Results-driven IT leader with 15+ years of proven experience in Digital IT Operations, GxP Compliance, Automation, Cybersecurity (IT/OT), Computer System Validation (CSV), and IT Infrastructure Management within pharmaceutical and global IT organizations. Demonstrated expertise in audit readiness, US-FDA and global regulatory compliance, and leading digital transformation initiatives that enhance operational reliability, system integrity, and business continuity.

Recognized for driving process optimization, innovation, and risk-based IT governance, while implementing scalable, compliant, and secure technology solutions aligned with organizational and regulatory objectives. Seeking to leverage strong technical acumen, strategic vision, and leadership capabilities to deliver operational excellence, compliance assurance, and continuous improvement in a high-performing, regulated environment. PROFESSIONAL EXPERIENCE: 15 Years

Infrastructure & Server Management Experience

Application & Database Admntinistration: Managed and monitored diverse application and database servers, ensuring high availability and optimal performance.

Network & Security Devices: Configured, monitored, and maintained IT/OT network devices and firewalls (Palo Alto, SonicWALL, Cisco) to deliver secure, reliable connectivity.

Backup & Recovery Systems: Directed backup servers and disaster recovery processes to safeguard critical data and maintain business continuity.

Active Directory & Policy Management: Administered AD, group policies, and file servers to enforce security standards and streamline user access.

Operational Reliability: Implemented proactive monitoring and troubleshooting practices, minimizing downtime and optimizing infrastructure performance. Process Excellence Initiatives

Continuous Improvement Culture: Actively contributed to IFQM, Outbound, Quality Circle, and Gemba audits to drive operational excellence.

Quality-Driven IT Practices: Aligned IT processes with organizational standards and regulatory expectations, strengthening compliance and audit readiness.

Cross-Functional Collaboration: Partnered with IT, manufacturing, and quality teams to deliver improvement initiatives.

Process Optimization: Supported programs that enhanced efficiency, reduced risks, and promoted continuous improvement.

Audit Readiness & Risk Reduction: Contributed to initiatives that improved audit preparedness while minimizing operational risks.

End-to-End Project Experience

IT Governance & Compliance: Developed and implemented IT policies and GSOPs, ensuring GxP and FDA compliance.

Vendor Management: Coordinated vendor and managed end-to-end project execution with external partners.

Digital Workplace Transformation: Deployed Office 365 solutions to enhance collaboration and productivity.

Digital Logs & Monitoring: Introduced e-logs for production and implemented Early Warning System (EWS) with EY to strengthen operational visibility.

Enterprise Applications: Led qualification and rollout of ERP Progen, Pharmacovigilance, and Abacube Cloud applications.

Laboratory Systems Modernization: Upgraded and migrated Caliber LIMS, Empower, OpenLab, and Chromeleon (6.8 & 7.2), supporting lab automation and data integrity.

Manufacturing Systems: Implemented and validated Werum Pas-X EBR, enabling paperless manufacturing and streamlined batch record management.

Serialization & Track-and-Trace: Deployed QR code solutions and track & trace systems

(ACG, Traclink, Rfxcel) to ensure product authenticity and compliance. Strides Pharma Science Limited (via Coforge Ltd), Bengaluru Oct 2025 – Present Senior Manager – Cluster IT Lead (KRSG Location)

Key Responsibilities & Leadership Scope

Direct end-to-end IT operations across multiple sites, ensuring uninterrupted business continuity, service availability, reliability, and security for plant and corporate users.

Hold overall accountability for IT infrastructure, digital transformation initiatives, GxP compliance, audit support and responses, IT projects, end-user services, and Computer System Validation (CSV) activities.

Manage IT infrastructure including servers, backups, storage, and networking; lead infrastructure projects, OS/firmware upgrades, downtime planning, patch management, and enhancement initiatives.

Oversee data center operations, including: Daily backup log review and restore readiness, Storage utilization and capacity planning, Server and network health monitoring Patch upgrades and preventive maintenance to minimize outage risks.

Participate in daily and weekly operational reviews with SLT members, CIMS Operations, IT leadership teams, QSR, and QRB, ensuring alignment with site objectives and organizational priorities.

Conduct daily reviews of: ITSM tickets and service requests, IT projects and deliverables, QMS deviations, change controls, and CAPAs, Effectiveness checks and investigation reports, Audit observations, qualification documents, and periodic compliance reports.

Digitally review, approve, and sign GxP and non-GxP documentation, and provide audit explanations and evidence during internal and external inspections to ensure compliance with GMP, GLP, FDA, and global regulatory standards.

Lead, mentor, and motivate cross-functional IT teams, fostering collaboration, accountability, productivity, and a culture of continuous improvement.

Define and implement strategic initiatives to improve team efficiency, reduce production downtime, and align IT services with evolving business and regulatory requirements.

Ensure strict adherence to company policies, SOPs, cybersecurity controls, and audit expectations, maintaining continuous readiness for regulatory inspections.

Collaborate closely with vendors, OEMs, support partners, and senior management to resolve operational issues promptly while maintaining high quality and compliance standards.

Spearhead cluster-wide IT operations and digital initiatives, driving operational efficiency while ensuring robust GxP, GMP, and regulatory compliance. Digital Transformation:

IT/OT Network Integration & Digitization: Led the integration of IT and OT networks, migrating legacy manual processes to secure, digital platforms to improve visibility, control, and compliance across manufacturing environments.

Applications being used: ITSM solutions to standardize service delivery, incident management, and SLA governance, ValGenesis Validation Lifecycle Management System

(VLMS) to standardize and streamline validation documentation, change control, and compliance tracking. Leucine e-Log (digital logbooks & shift records), TrackWise (QMS & CAPA management, Syncade (eBMR) for electronic batch manufacturing and paperless operations, SAP for enterprise planning and operations, ComplianceWire (LMS) for regulated training and competency management, IBPS Document Management System for controlled documentation

Dr. Reddy's Laboratories Ltd (via Fidelies Pvt. Ltd.) Visakhapatnam Mar 2025 – Sept 2025 Unit Lead – IT (Digital Operations & GxP Compliance); Units: FTO 7, 9 & 11 Key Responsibilities & Leadership Scope

Ensured stable IT operations and continuous GxP compliance across manufacturing units.

Delivered IT infrastructure availability and service reliability to support uninterrupted plant operations.

Supported servers, data backups, and networking infrastructure, including system upgrades and enhancements.

Digitally reviewed, approved, and signed GxP and non-GxP documentation, and provided explanations during audits and inspections.

Implemented corporate IT policies and SOPs, developed plant-specific procedures, and ensured audit-ready documentation.

Participated in daily LDM and periodic QRB reviews with Site SLT and Corporate IT to align IT operations with business objectives.

SUN PHARMA LABORATORIES LTD Guwahati Dec 2022 – Feb 2025 Manager – IT (Department Head, OSD & NOSD Units)

Key Responsibilities & Leadership Scope

Led end-to-end IT operations, ensuring continuous GxP compliance across manufacturing units.

Prepared and managed IT Capex/Opex budgets, AMC renewals, license management, and IT asset procurement.

Oversaw data center operations, including backup monitoring, storage utilization, server/network health checks, and preventive maintenance.

Implemented corporate IT policies and GSOPs at site level.

Prepared and submitted weekly and monthly MIS reports.

Participated in SLT and Corporate reviews (PD, QRB, budget and Capex planning).

Coordinated with centralized IT teams for enterprise application rollouts.

Provided IT infrastructure support during regulatory, customer, and internal inspections. Key Achievements

Successfully managed a cyberattack and full data recovery (Mar 2023) with minimal business disruption.

Strengthened Business Continuity Planning (BCP) through IT risk mitigation strategies.

Enhanced security through FireEye, CrowdStrike, DLP, and Trend Micro Deep Security.

Enforced patching, OS upgrades, removal of generic IDs, VMware ESXi and firmware upgrades.

Implemented USB restrictions, Wi-Fi SSID hardening, and access monitoring.

Resolved the global CrowdStrike BSOD issue (Jul 2024) across Windows systems. Project Work

Implemented QR code system (PharmaSpec) in OSD block.

Supported new area expansions, network cabling, vendor coordination.

Implemented E-Log systems, TantraSoft, and NVR-based CCTV surveillance. Process Excellence

Actively participated in IFQM, Outbound audits, Quality Circles, and Gemba walks.

Drove quality-driven IT practices and cross-functional collaboration with Manufacturing and QA teams.

Ajanta Pharma Ltd. Bharuch, Gujarat Oct 2021 – Sept 2022 Assistant Manager – IT (Department Head)

Key Responsibilities & Leadership Scope

Managed data center operations, GxP Compliance, firewall, server/network/ bandwidth utilization, backups, NAS storage, domain, and local security policies.

Supported IT Capex/Opex budgeting, PR processing, and vendor payments via SAP. Projects

Implemented Werum PAS-X EBR with Sarala Solutions.

Deployed Early Warning System (EWS) for lab applications with EY. Achievements

Successfully supported USFDA, Zambia, and Kenya audits with zero critical IT observations.

Cadila Pharmaceuticals Ltd Ahmedabad, Gujarat 2019 – Oct 2021 Senior Executive – IT (IT-QA & Site IT In-Charge)

Key Responsibilities & Leadership Scope

Served as SPOC for CSV and IT-QA activities.

Monitored GxP systems, backups, inventories, audit trails, and IT QMS.

Prepared IT SOPs, URS, GAP analysis, and validation documentation.

Participated in FAT, vendor audits, DQ/IQ/OQ reviews. Projects

Upgraded Chromeleon 7.2, Empower, LabSolutions.

Implemented Track & Trace (ACG, Rfxcel).

Validated LCMS, Glatt, FETTE, CEIA, LIS, barcode systems.

Integrated PLC/SCADA and corporate networks.

Supported Industry 4.0 and paperless initiatives. Achievements

Supported USFDA and global customer audits with appreciation from auditors and Plant Head.

Concord Biotech Ltd. Formulation Unit Ahmedabad, Gujarat 2018 – 2019 IT Executive (Site IT In-Charge)

Key Responsibilities:

Managed plant-wide IT operations across lab, manufacturing, and admin functions.

Implemented ERP Progen, Track & Trace, and Abacube Cloud. Achievements

Supported USFDA and customer audits with zero IT observations. Accenture services Pvt Ltd Ahmedabad, Gujarat 2015 – 2018 IT Operations Analyst (Client: Zydus Cadila Healthcare Ltd) Key Responsibilities & Leadership Scope

Managed FMS team of 20 engineers.

Prepared IT GSOPs, Software Process Steps, Privilege Right Matrix, and maintained documentation to strengthen IT governance and audit readiness.

Administered GxP systems, implemented system control policies, and verified audit trails

& electronic data integrity.

Project Work

Prepared and rolled out IT GSOPs across multiple Zydus locations.

Standardized IT operations by deploying domain policies across Zydus sites. Achievements

Supported multiple USFDA audits and Lachman audit.

Received Champion Trophy (Accenture) and Silver Coin (Zydus) for excellence. Accel-Frontline Ltd. Mumbai July 2012 – Dec 2015 System Administrator – Client: Exim Bank

Provided L2 support to the user calls and infrastructure support for servers

(IBM/Dell/HP), firewalls (Palo Alto, SonicWALL, Cisco), AD, Exchange, backups.

Supported banking and enterprise applications including Finacle Treasury, SharePoint, HRMS, Dark Management, and e-Token.

Achievement

Awarded Best Performance Recognition (Mumbai Region). ACADEMIC QUALIFICATIONS:

PERSONAL DETAILS:

Date of Birth: 31 August 1985

Languages Known: English, Hindi, Oriya, Telugu, Marathi, Gujarati

Address: Odisha, India

DECLERATION:

I hereby declare that the information furnished above is true and correct to the best of my knowledge and belief. I take full responsibility for the accuracy of the details provided herein. Place: Bengaluru Signature: Date: 2026 Name: Nageswar Rao

Name of the

Examination

Board /University

Year of

Examination

Class

MBA IITMS (Imperial Institute of Technical &

Management Studies)

2023 A Grade

B. Com Mumbai University 2011 Second Class

H.S.C Pune University 2005 Pass Class

S.S.C Odisha 2003 Second Class

Additional Computer Courses & Certifications

MC-ITP 2008 Certification, Red Hat,

and CCNA

CMS Institute – Mumbai 2013 First Class

Computer Teacher Training Course

and Hardware & Networking

Silver Trek Computer

Institute – Mumbai

2006 First Class

Training Programs & Certifications

Computer System Validation (CSV) Epitome Technologies May 2016 Certification Computer Software Assurance (CSA) EBM Feb 2022 Certification

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