Digitalization IT Operations GxP Compliance

Master’s Program MBA in Information Technology

MCITP (Microsoft Certified IT Professional), CCNA & Read hat Linux, Certification in “Computer Teacher Training Program and Computer Hardware & Networking” Computer System Validation, GxP compliance and Documentation practices: CSV (Computer System Validation) in May 2016, conducted by Epitome Technologies. CSA 2nd Annual (Computer Software Assurance) 2022 in Feb, conducted by (EBM). NAGESWAR RAO

Digital IT Operations GxP Compliance Infrastructure Management CSV Address: Odisha

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

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

CAREER OBJECTIVE:

Results-driven IT leader with 15+ years of expertise in Digital IT Operations, GxP Compliance, Automation, Cybersecurity, Computer System Validation (CSV), and IT Infrastructure Management within pharmaceutical and top- tier IT organizations. Demonstrated success in ensuring audit readiness, driving FDA regulatory compliance, and leading digital transformation initiatives that strengthen operational reliability and business continuity. Adept at fostering innovation, streamlining processes, and implementing scalable IT solutions aligned with organizational goals. Seeking to leverage technical acumen, strategic vision, and leadership skills to contribute to a high-performing organization committed to operational excellence, compliance, and continuous improvement. PROFESSIONAL EXPERIENCE: 15 Years

End-to-End Project Experience:

IT Governance & Compliance: Preparation and implementation of IT policies and GSOPs ensuring GxP and FDA regulatory compliance.

Vendor Management & Execution: Coordinated with vendors, conducted vendor audits, and provided implementation and support throughout project lifecycles.

Digital Workplace Transformation: Deployed Office 365 products to enhance collaboration, communication, and productivity.

Digital Logs & Monitoring: Introduction of e-logs for production and Implemented Early Warning System (EWS) with EY to improve operational visibility and proactive risk management.

Enterprise Applications: Led Qualification and rollout of ERP Progen, Pharmacovigilance, and Abacube Cloud applications for integrated business operations.

Laboratory Systems Modernization: Upgradation and data migration of Caliber LIMS, Empower, OpenLab, and Chromeleon (versions 6.8 & 7.2), supporting lab automation and data integrity.

Manufacturing & Production Systems: Implemented and validation EBR Werum Pas-X with Sarala, enabling paperless manufacturing and streamlined batch record management.

Serialization & Track-and-Trace: Deployed QR code solutions with Pharma Spec and track & trace systems with ACG, Traclink, and Rfxcel to ensure product authenticity and regulatory compliance. Process Excellence Initiatives:

Continuous Improvement Culture: Actively participated in IFQM, Outbound, Quality Circle, and Gemba Audits to drive a culture of quality and operational excellence.

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

Cross-Functional Collaboration: Played a key role in improvement initiatives by fostering collaboration between IT, manufacturing, and quality teams.

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

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

Infrastructure & Server Management Experience:

Application & Database Administration: Managed and monitored different application servers, database servers to ensure high availability and performance.

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

Active Directory & Policy Management: Administered local and group policies, Active Directory

(AD), and file servers to enforce security standards and streamline user access management.

Network & Security Devices: Configured, monitored, and maintained network devices and firewalls, including Palo Alto, SonicWALL, and Cisco, to ensure secure and reliable connectivity.

Operational Reliability: Implemented proactive monitoring and troubleshooting practices to minimize downtime and optimize IT infrastructure performance. Strides Pharma Science Ltd, (via Coforge Ltd), Bengaluru Oct 2025 - Present Cluster Lead – IT, Key Responsibilities:

Oversee day-to-day IT operations across multiple sites, ensuring availability, reliability, and security of IT services.

Overall responsibility for IT infrastructure, GxP compliance, audit support, IT projects, digitalization, end-user support, team management, and support on computer system validation.

Preped IT budgets - Capex and Opex, ensured timely renewal of AMC contracts, licence renew, procurement of IT Assets in coordination with corporate teams.

Oversaw datacenter operations, data backup logs, storage utilization, server/network health checks, and preventive maintenance to minimize risks of outages.

Conduct daily reviews of IT tickets, projects, QMS, deviations, change controls, CAPA effectiveness checks, data backup logs, qualification documents, periodic reports, investigations, and audit observations.

Manage and monitor application/database servers, backup logs, and network devices to ensure operational continuity.

Lead, mentor, and motivate IT professionals, fostering collaboration, productivity, and continuous improvement.

Develop and implement strategies to enhance team efficiency and align IT services with business needs.

Ensure adherence to company policies, SOPs, security protocols, and audit requirements, maintaining readiness for internal and external inspections.

Participate in daily/weekly meetings with SLT members (Production, QC, QA, WH, HR), IT leads, CIMS operations, QSR reviews, and QRB reviews.

Collaborate with vendors, support teams, and senior management to resolve operational issues and uphold quality standards.

Conduct periodic reviews of IT SOP compliance, including data backup, user privileges, and role matrix for laboratory and manufacturing applications.

Spearhead IT operations and digital initiatives across the cluster, driving continuous improvement while ensuring strict compliance with GxP, GMP, and regulatory standards. Dr. Reddy’s Laboratories, (via Fidelies Pvt Ltd), Visakhapatnam Mar 2025 - Sept 2025 Unit Lead-IT (Digital Ops. & GxP Compliance) Unit FTO 7, 9 & 11 Key Responsibilities:

Ensured smooth IT operations and maintained continuous GxP compliance across plant units.

Implemented IT solutions with a strong focus on compliance, project execution, and timely delivery.

Provided IT infrastructure and service availability to plant users, enabling uninterrupted business operations.

Oversaw routine maintenance of data centers, servers, patch updates, GxP systems, and network devices to minimize risks of outages.

Supported IT infrastructure for servers, data backup, and networking; managed site infra projects, upgrades, and enhancements.

Adopted corporate IT policies and SOPs, developed plant-specific SOPs, and ensured accurate documentation for audits and inspections.

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

Participated in daily LDM and periodic QRB review meetings with site SLT and corporate teams to align IT operations with business needs.

Delivered additional support for laboratory, production, and manufacturing systems, including Computer System Validation (CSV) and system breakdown resolution.

Directed IT department resource allocation and management across plant sites. Sun Pharma Laboratories Ltd, Guwahati Dec 2022 - Feb 2025 Manager – IT (Department Head-IT, UNIT-OSD & NOSD) Key Responsibilities:

Ensured smooth IT Operations and maintained continues GxP Compliance across plant units.

Preped IT budgets - Capex and Opex, ensured timely renewal of AMC contracts, licence renew, procurement of IT Assets in coordination with corporate teams.

Oversaw datacenter operations, data backup logs, storage utilization, server/network health checks, and preventive maintenance to minimize risks of outages.

Implemented central IT policies and GSOPs at site level.

Prepared and submitted weekly/monthly MIS reports.

Participated in SLT and corporate review meetings (PD, QRB, budget, Capex discussions) to align IT operations with business priorities.

Coordinated with centralized IT teams and site users for implementation of enterprise applications and projects.

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

Played a key role in managing a global IT security incident (Sun pharma) and data recovery process

(Mar 2023), ensuring minimal business disruption.

Contributed to Business Continuity Plan (BCP) by aligning IT infrastructure with risk mitigation strategies.

Strengthened network, server, database, and endpoint security through deployment of tools like FireEye, CrowdStrike, DLP, and Deep Security.

Enforced patch updates, eliminated generic IDs, and upgraded outdated OS, VMware ESXi, and firmware across IT infrastructure.

Implemented USB restrictions, SSID Wi-Fi hardening, and unauthorized access controls while actively monitoring network behavior and user activity.

Addressed the global CrowdStrike “Blue Screen” error (Jul 2024), mitigating impact on Windows systems and coordinating recovery efforts across Sun Pharma. Process Excellence Initiatives:

Participated Continuous Improvement Culture: Actively participated in IFQM, Outbound, Quality Circle, and Gemba Audits to drive a culture of quality and operational excellence.

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

Cross-Functional Collaboration: Played a key role in improvement initiatives by fostering collaboration between IT, manufacturing, and quality teams. Project Work:

Successfully deployed QR code system in OSD block within time timeline using PharmaSpec for enhanced traceability.

Supported new area expansions, Network Cable laying, Vendor coordination, including E-Log, Tantra Soft, and NVR CCTV implementation, improving digital infrastructure and surveillance capabilities.

Ajanta Pharma Ltd, Bharuch, Gujarat Oct 2021 - Sept 2022 Asst. Manager – IT (Department Head, reporting to Sr. VP, Plant Head Operations) Key Responsibilities:

Supported IT budget planning (Capex & Opex), managed PR processes, and vendor bill payments through SAP.

Oversaw datacenter operations, data backup logs, NAS storage, server/network utilization, health checks and internet bandwidth.

Implemented firewall security policies, domain policies, and local policies aligned with business requirements.

Project Work:

Implemented EBR Werum PAS-X in collaboration with Sarala, streamlining electronic batch recording processes.

Deployed Early Warning System (EWS) for laboratory applications in partnership with EY, enabling proactive issue detection and resolution.

Achievements:

Successfully supported regulatory audits (USFDA, Zambia, Kenya) with no critical IT observations, demonstrating strong compliance and audit readiness. Cadila Pharmaceuticals Ltd, Ahmedabad, Gujarat 2019 - Oct 2021 Sr. Executive – IT (IT-QA & Site IT in-charge, reporting to Sr. Vice President-IT) Key Responsibilities:

Served as Single Point of Contact (SPOC) for business stakeholders, leading Computer System Validation (CSV) activities.

Monitored GxP servers, data backup logs, and provided technical support to ensure operational continuity.

Performed administrative activities in GxP applications, laboratory, production, manufacturing, LIMS, and IT systems.

Prepared IT SOPs, URS, IT Documents, conducted GAP analysis, and ensured audit readiness.

Participated in FAT discussions, Vendor Audit.

Reviewed vendor DQ, IQ, OQ documents and qualification CSV documents.

Managed GxP inventory, IT QMS, and verified system audit trails. Project Work:

Upgraded and migrated data for Lab-Solution, Chromeleon 7.2, and Empower software.

Upgraded and validated track & trace systems with ACG and Rfxcel.

Implemented and validated LCMS, Glatt, FETTE, CEIA metal detector, 2D barcode, and LIS systems.

Rolled out corporate network integration in production and manufacturing PLC SCADA systems.

Contributed to paperless project and Industry 4.0 initiatives (real-time data monitoring), including SAP Sprint risk assessment.

Achievements:

Successfully supported USFDA, South African, and other customer regulatory audits (2019) with strong IT compliance.

Clearly articulated IT roles and responsibilities across laboratory and manufacturing systems, ensuring operational alignment.

Earned formal appreciation from auditors and Plant Head for proactive engagement and audit readiness.

Concord Biotech Ltd. Formulation Unit, Ahmedabad, Gujarat 2018 to 2019 IT-Executive - IT In-charge

Key Responsibilities: -

Led and managed site-wide IT operations, ensuring compliance and seamless support across manufacturing, laboratory, and administrative functions. Project Work:

Deployed and validated ERP, Track & Trace system with ACG and Rfxcel.

Rolled out Abacube Cloud applications to facilitate secure document submissions to regulatory agencies.

Achievements:

Successfully supported USFDA, customer audits, and Microsoft license compliance review, achieving zero IT observations.

Received formal appreciation from auditors and Plant Head for audit preparedness, responsiveness, and excellence in IT governance.

Accenture Solutions Pvt Ltd, Ahmedabad, Gujarat 2015 to 2018 IT-Operation Analyst – Client Zydus Cadila Healthcare Ltd Key Responsibilities: (IT-CSV SME & Site IT-In-Charge)

Managed the Facility Management Services (FMS) team of 20 members, analyzing daily calls and ensuring timely resolution.

Prepared IT SOPs, Software process steps to strengthen IT governance, Privilege Right Matrix, Maintained documentation, and ensured audit readiness.

Oversaw user account management in GxP applications, implemented system control policies, verified audit trails, electronic data.

Project Work:

Prepared IT GSOPs and implemented them across Zydus locations.

Deployed domain policies across multiple Zydus sites to standardize IT operations. Achievements:

Successfully participated in multiple USFDA audits (2016–2018) and a Lachman audit, ensuring full IT compliance and readiness.

Effectively explained IT roles and responsibilities in managing GxP systems during audits.

Received “Champion Trophy Award” from Accenture and a “Silver Coin” from Zydus Cadila for excellence in IT operations and compliance.

Accel-Frontline Ltd. Mumbai 2012 - Dec 2015

System Administrator – Client: Exim Bank

Key Responsibilities:

Provided L2 remote support, managed and troubleshot server hardware issues (IBM/Dell/HP), and coordinated with vendors using OEM diagnostic tools.

Monitored and managed network firewalls (Palo Alto, SonicWALL, Cisco), backup servers, Active Directory, Exchange servers, POP3, and file/print servers.

Oversaw IT infrastructure and supported banking applications including SharePoint, Finacle Treasury, NDS Server, Digital Signature (e-Token), HRMS, Intranet, Dark Management, Spark Messenger, COE-Notes, VC room setup, wireless presentation sharing, and telepresence connectivity. Achievements: Awarded Best Work Performance recognition from the Mumbai region for excellence in IT operations and support.

Geekay InfoTech - Reliance InfoTech, Mumbai 2011 - 2012 Sr. Technical Support Engineer (Desktop Support)

Key Responsibilities:

Provided end-user support for desktops and laptops, ensuring smooth IT operations at Reliance InfoTech’s Mumbai location.

Handled hardware/software issues, performed system upgrades, and ensured timely resolution of technical problems.

Supported employees with application usage, connectivity, and system configurations to maintain productivity.

Assisted in routine IT tasks including system monitoring, patch updates, and compliance with organizational IT standards.

ACADAMIC QUALIFICATION:

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

PERSONAL DETAILS:

Date of Birth : 31 Aug, 1985

Languages Knowns : English, Hindi, Oriya, Telugu, Marathi & Gujarati. Address : Odisha, India.

DECLARATION:

I hereby declare that the above-mentioned information is correct up to my knowledge and I bear responsibility for the correctness of the above-mentioned particulars. Place: Bengaluru Signature:

Date: 2026 Nageswar Rao

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