Digital IT Ops. & 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

Address: Mumbai

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

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

CAREER OBJECTIVE:

Seeking a dynamic and challenging role within an organization where I can leverage my technical expertise, analytical skills, and industry knowledge. I am passionate about sharing experience, fostering professional growth, and contributing to a high-performing, state-of-the-art team. WORK EXPERIENCE: Total 15 years of experience

IT-Digital Operations: Managing automation, cloud services, cybersecurity, and overall IT workflows to enhance business efficiency.

GxP Compliance: Ensuring IT systems meet regulatory requirements such as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) for industries like pharmaceuticals and healthcare.

IT-Infrastructure: Overseeing Data Centre, Physical Servers, VM servers, File server, Network devices, Firewall, Antivirus Crowd Strike, Deep Security, AD, Group policy, Data backup Agents Actifio/Netveritas/Veem Agent/ECM Agilent tool, software systems, and security frameworks for reliable IT performance.

Leading IT-CSV Role (Computer System Validation): Overseeing validation activities for IT systems used in laboratory, production, and manufacturing environments to maintain regulatory compliance.

Global IT Incident (Security Threats): Handling cyberattacks, data breaches, malware intrusions, and system vulnerabilities across international IT infrastructures. Includes threat detection, mitigation, forensic analysis, and post-incident reporting.

Data Recovery Process: Developing backup strategies, disaster recovery plans, and failover mechanisms to restore lost or corrupted data efficiently. Involves real-time replication, offsite storage, and automated recovery testing to ensure business continuity.

Business Continuity Plan (BCP): Preparing organizations to sustain operations during crises, including natural disasters, cyber incidents, and infrastructure failures. Includes risk assessment, disaster recovery, and contingency planning for IT systems and critical business processes.

GSOPs (Global Standard Operating Procedures) & Central IT Policy: Reviewing and implementing IT policies at a site to maintain uniform security practices and regulatory compliance.

Network Security: Ensuring secure firewalls, encryption, and access controls to prevent unauthorized access or data breaches.

Server Vulnerability Management: Conducting regular vulnerability assessments, patch updates, and hardening measures to mitigate risks.

Business Email Phishing Prevention: Deploying anti-phishing filters, security training, and multi- factor authentication to protect users from fraudulent attacks.

Database & Client Systems Security: Implementing data encryption, backup strategies, and access control policies to ensure information integrity.

Generic ID Management (Windows & SQL DB): Controlling shared or generic accounts by enforcing strict authentication policies, audit trails, and role-based access management.

Self-Inspection as an IT-Inspector: Conducting internal audits to verify IT systems comply with security policies and industry regulations (such as GxP, ISO standards, or FDA guidelines). Identifying vulnerabilities in network infrastructure, database security, software compliance, documenting findings and recommending corrective actions to improve IT controls before external audits

Vendor Audit: Evaluating IT vendors and suppliers to ensure their services align with company security policies, quality expectations, and regulatory standards. Reviewing contract adherence, service-level agreements (SLAs), and cybersecurity compliance. FAT (Factory Acceptance Testing): Testing IT systems and hardware at the vendor’s site before final deployment. validating software functionality, network compatibility, and security configurations to ensure readiness for operational use. Ensuring proper documentation is maintained for regulatory and compliance purposes.

Experience in regulatory Audit & Audit compliance, Like: US-FDA, WHO, DCGI, MHRA, External agency audits, internal CQA audits, Microsoft IT audit, ensuring software licensing, IT resource allocation, and system security meet Microsoft compliance requirements.

Experience in IT-QMS: Track-wise, LIMS, eVal, Docuhb for the Process of Change Management, Incident, CAPA, Deviation, EDAMS and LMS, EDMS.

Technical support: Business Applications, Production & Manufacturing applications, such as SAP Sprint & SAP S/4 HANA, ERP Progen, Trackwise, LIMS, EDMS, EDAMS, QR-Code, Track & Trace system, etc.

Experience in managing projects:- Office 365 & Microsoft One Drive, Crowd Strike & Fire eye, DLP security, EBR Werum Pas-X with Sarala, Track & Trace System with ACG/Traclink/Rfxcel, QR Code with Pharma Spec, up-gradation of Lab systems & Manufacturing equipment’s, GSOPs implementation at site, Cloud base solution implementation, supporting to the in-house programing development team, Upgradation & Data Migration of Labsolution & Empower 3 & 3.7, Open Lab 2.5, Upgradation of Calibre LIMS, Chromeleon 6.8 & 7.2, EWS (Early Warning System) with EY, Veeam backup agent, different Antivirus, etc. I have attained a strong knowledge in the fundamentals of IT Systems Security, Quality and IT compliance systems and realised their practical applications through my industrial experience. Over the last 10 years of my pharma Professional experience, my key areas of involvement were in the areas of IT Operations, Compliance, & facilitating the support. My Experience has not only enabled me to attain technical skills and realise their practical viability, but also Fetched me sound organisational skills, interpersonal skills, professionalism and problem- solving Capabilities.

Dr. Reddy’s with “Fidelies Corporate Solution Pvt Ltd”, at (Vizag, Visakhapatnam) From 01 Mar, 2025

Role and Responsibility: DRL-Unit Lead – IT (Digital Ops. & GxP) (Unit FTO 7, 9, & 11)

Ensuring Smooth GxP IT Operations & Compliance at the site, ensuring that IT Operations in the plant are running smoothly.

All-time GxP IT Compliance at Plant and Implement Solutions with Project Execution & Delivery focus.

Business Support Initiatives and Ensuring the availability of IT infrastructure and services to plant users.

Ensure Routine Preventive Maintenance of Data Centre, Servers, patch updating, GxP Systems and Network devices for smooth operations and to prevent the risk of network/server outages.

To support the IT infrastructure for Servers, Data Backup and Networking at the site.

Responsible for the site Infra Projects, Infrastructure Management and Upgradation.

Participation in the daily & periodic review meeting with site SLT and Corporate team.

Be a part of the internal audit team at the site/cluster as an SME on IT systems and the IT engineers team management.

To support regulatory, customer, or internal inspection concerning IT Infra and IT System- related queries.

Be involved in IT-related incidents as an investigation team member and ensure that necessary CAPA is implemented.

Coordinate with Vendors, service providers, or Business functions for the resolution of any applications, IT services, or IT functional issues.

Adopt corporate polices and standard operating procedures (SOPs) and, if required, develop plant-specific SOPs for all IT activities that need to be performed in the plant.

Ensure adherence to organizations/site/department (IT) policies, guidelines, and procedures and ensure generation of adequate and accurate documentation.

Resource management process for the IT department at the sites.

Sign, review, and approve both GxP and Non-GxP documents, whether physical or electronic, and be responsible for explaining these documents during any inspection or audit.

Providing additional support and Guidance on Laboratory, Production, & Manufacturing systems, Computer System Validation (CSV) and breakdown support. Sun-Pharma Laboratories Ltd,

Manager-IT at (Guwahati, Assam) From 19 Dec, 2022 to 26 Feb, 2025 Role and Responsibility: Department Head (OSD & NOSD)

Handling of IT-Operations & Compliance.

Preparation of IT Budget, Capex and Opex budget for the IT function at the site.

Resource management process for the IT department at the sites.

To support IT infrastructure for Servers, Data Backup and Networking at the site.

Responsible for the site Infra Projects, Infrastructure Management and Upgradation.

To monitor the IT data centre / Physical Servers/ VM/ Storage/ Network HUB/ CCTV/Data Backup log / Storage Utilization / Server & Network utilization, and Health Check-up.

Escalation of critical/major/moderate issues or concerns to seniors / centralized IT Team for priority resolution.

Participation in the daily & periodic review meeting with site SLT and Corporate team, Weekly PD, QRB meeting, Budget & Capex discussion, etc.

Coordination with centralized IT Team & site users for implementation/rollout of centralized applications/projects.

Coordinate with Vendors, service providers, or Business functions for the resolution of any applications, IT services, or IT functional issues.

Implementation of central IT Policy and GSOPs at the site level.

Analysing any new business requirement and discussing with the internal or centralized IT Team for resolution, resource planning, allocation, monitoring, etc. for H/W, N/W, and S/W.

Preparation and submission of the weekly and monthly MIS report.

To support regulatory, customer, or internal inspection concerning IT infrastructure-related queries.

Responsible for the IT-Audit response, IT QMS and Compliance.

Ensure adherence to organizations/site/department (IT) policies, guidelines, and procedures and ensure generation of adequate and accurate documentation.

Ensure AMC is renewed within the timeframe in coordination with the corporate team.

Ensure Routine Preventive Maintenance of Data Centre, Servers, GxP Systems and Network devices for smooth operations and to prevent the risk of network/server outages.

Providing additional support and Guidance on Laboratory, Production, & Manufacturing systems, Computer System Validation (CSV) and breakdown support. Project Support and Achievements: -

Participated in the IFQM, Outbound, Quality Circle, Gemba Audit and other process improvement programs.

Good Experience on Global IT Incident (Security Threats) & Data recovery process across Sun Pharma in Mar 2023 and Business Continuity Plan.

2nd instant of Crowd Strike “Blue screen error” Across Sun pharma due to Crowd Strike patching issue and effect in Windows based systems, resulting in frequent system restart due to global outage issue (July 2024).

QR code system implementation in OSD block with Pharma Spec.

Implementation of High network security, Server, database, client systems, business email phishing using Fire eye, Crowd Strike, DLP, Deep security, regular patch update, prevent Generic ID (Database/Server/Client), Outdated Server OS, Client OS, VM, Network firmware, Network firewall, SSID Wi-Fi, prevent of un-Authorize access, USB limited access, Monitoring of network behaviour and user activity.

Project support for the new area expansion, E-log, Tantra Soft and NVR CCTV implementation.

Working on timely patches upgradation, upgradation on outdated OS/Database, working on Generic ID’s in the Server/Client/Database, monitoring of Server & Network utilization and usage.

Ajanta Pharma Ltd, Asst. Manager (Bharuch, Gujarat) from 2021 to 2022 Role and Responsibility: Department Head, reporting to Sr. VP (Plant Head Operations)

Responsible for IT Operations, Compliance and Team management (Infra and CSV Team).

To support the Budget, Capex, and Opex planning.

To carry out the PR and vendor bill payment in the SAP system.

Resource management process for the IT department at the site.

To support IT infrastructure for servers, Data Backup and Networking, Firewall at the site.

Monitoring of Datacentre / Data Backup log / Internet bandwidth utilisation / NAS Storage / Storage Utilisation / Server & Network utilisation and Health Check-up.

Deploying the Firewall security policy, Domain policy and Local policy as per business requirements.

To perform the administrative activity in LIMS, QMS, TRIMS, and GxP applications available in QC, Production, and Manufacturing equipment, Citrix,

To support Computer System Validation as per GAMP-5 and V- module.

Responsible for the QMS (Incident, Change control, Deviation, CAPA).

Participate in the Self-Inspection.

Project works & Key Achievements:

EBR Werum Pas-X with Sarala, ACG-Track & Trace system upgradation, EWS (Early warning system) for Laboratory applications with EY team, E-logs for production, E-LIMS at QC, Simplify the network connectivity and implement the network connectivity in Production & Manufacturing equipment’s for Auto data backup configuration (Acronic backup solution). Successful regulatory USFDA audit in Sep 05, 2022 to Sep 09, 2022 and Zambia & Kenya audit in Feb 2022.

Cadila Pharmaceuticals Ltd (Ahmedabad, Gujarat) Sr. Executive from 2019 to 2021 Role and Responsibility: IT QA and site IT- in charge, reporting to Sr. Vice President-IT

Leading the IT-CSV role and Single Point of Contact (SPOC) to business stakeholders.

Technical support in GxP servers and GxP applications.

Supporting the programming development team in developing in-house applications and the execution process.

Preparation of IT-SOPs and documentation, GAP analysis, and audit preparation.

To monitor and deploy IT policy in GxP systems, Laboratory, production & manufacturing systems.

Performing administrative activity in GxP applications Laboratory QC, Micro, Production & Manufacturing, LIMS systems, IT applications MMD, DMS, MDM, HR Success Factor, Laboratory applications, and Production & Manufacturing systems, ACG Track & Trace Systems, 2D Barcode Noxview, NKP system, Fette, Glatt system, Chromeleon, Empower, Lab solution, KF, Polarimeteor etc.

To manage and update the GxP-Inventory (Applications and Hardware).

Periodically review and verification of system audit trial & electronic data backup.

Responsible for QMS process (Change control impact assessment, Deviation and CAPA in LIMS systems).

Reviewing URS and DQ, IQ & OQ documents and FAT points discussion. Project works:

SAP Sprint risk assessment.

Implementation of corporate network in Production & Manufacturing PLC SCADA systems & other systems to configure the Auto data backup schedule, installation Antivirus, Time synchronization etc.

Track & Trace system upgradation and performing the CSV with ACG & Rfxcel team.

Lab-Solution and Empower software up-gradation and Data migration.

New Chromeleon 7.2, LCMS, Glatt, FETTE, CEIA metal detector, 2D Barcode, and LIS system implementation and Validation.

Paperless project & Industry 4.0 project (Real time data monitoring) ongoing. Key Achievements:

Faced USFDA, South Africa and other regulatory Audits in 2019. Explained IT role and responsibility in Laboratory & manufacturing systems, system security policy, User Account Management part, Data archive process and disasters recovery process.

IT observation points are cleared within time line and Audit, success without plant observations. Nominated and appreciated by Auditors, and Plant Head. Concord Biotech Ltd. Formulation Unit (Ahmedabad, Gujarat) IT-Executive from 2018 to 2019 Role and Responsibility: IT- In charge

Handling of IT Operations and Infrastructure management.

Supporting and Managing AD, Antivirus, Network firewall, VPN, Security patches updating in ERP Progen, HPLC, Standalone, RADOC, Data backup configuration & monitoring and other Business applications.

Managing GxP applications and performing the Infrastructure validation.

Audit preparation and responsible for the Audit and audit compliance.

Responsible for managing IT Inventory, Preparation of IT-SOPs & Documentation.

To review cross-functional department documents, URS, DQ, CC, CAPA, Deviation and SOP’s. Completed Projects: End-to-End

Track & Trace system implementation and validation.

ERP Macro vision system implementation and Validation with different modules.

Cloud-based application for the RA dept. to send Douser Documents to the regulatory agency. Key Achievements: Zero observations from the IT side

Faced USFDA audit on 19th Oct, 2018, Explained IT role and responsibility in Laboratory applications, IT-Policy on GxP systems, Data disaster process, Micro applications TOC-L, and Excel spreadsheet related. Good learning and experience to face an auditor.

Mylan audit in Feb 2019, Client EUGMP audit and Lupin audit from 29th July to 31st July, 2019.

IT observation points are cleared within the timeline, appreciated by the Auditor and Company CEO, Lab HOD, and IT GM for timely clearing the audit observation points.

Audit faced: USFDA, Microsoft and other Externa agency audits. Accenture Solution Pvt Ltd. (Ahmedabad, Gujarat) IT-Operation Analyst At Zydus Cadila Healthcare Ltd., Moraiya plant from 2015 to 2018 Role and Responsibility: IT-CSV (SME) and Site IT-In-Charge

Responsible for site IT-compliance and to face Regulatory Audit & Audit response.

Managing and monitoring of different servers (Backup server, HPLC, Standalone & Open LAB ECM (Enterprise Content Manager) server).

Responsible for Datacentre management and reviewing data backup logs.

Handling the IT-FMS Team of 20 members and Analysis of daily calls.

Preparation of IT-SOPs and documentation, audit plan for USFDA, WHO, DCGI, Customer audit and Internal QA/CQA & External audit CQA.

Responsible for User Account Management in GxP applications, Verification of system audit trail and Electronic data, preparation of software process steps and Privilege Right Matrix.

Implementation of laboratory system control policy to ensure 21 CFR part 11.

To perform software validation with the Internal GLP Team and Service Engineer (IQ, OQ & PQ) and PRM challenge Test.

Key Achievements:

Champion Trophy award received from Accenture and a Silver coin from Zydus Cadila.

Audit experience, USFDA audit from 2016 to 2018 and Lachman Audit, explained IT role and responsibility in GxP systems and Data archival process. Accel-Frontline Ltd. System Admin (Mumbai) 2012 to 2015 Client: Export Import Bank of India (Head Office-Mumbai), and GroupMTech Role and Responsibility: System Admin and Remote Support Key Achievements: Best work performance award from the Mumbai region. Geekay InfoTech, Reliance InfoTech at Mumbai

Sr. Technical Support Engineer from 2011 to 2012

Desktop Support at Reliance InfoTech, Mumbai location. 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 Courses:

Computer Course &

Certification:

MC-ITP 2008 Certification,

Read Hat and CCNA

CMS Institute - Mumbai 2013 First Class

Computer Teacher Training

Course for Hardware and

Networking

Silver Trek Institute - Mumbai 2006 First Class

PERSONAL DETAILS:

Father Name : Ghanshyam Pedini

Mother Name : Pedini Kurei

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: Vizag, Visakhapatnam

Date: Jun 2025 Nageswar Rao

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