IT Operations & Compliance, IT Infrastracture and Applications Support
Resume:
Master’s Program MBA in Information Technology
Microsoft Certification on MCITP 2008, CCNA & Read hat Linux Computer System Validation, GxP compliance and Documentation practices:
CSA 2nd Annual (Computer Software Assurance) 2022 in Feb, conducted by (EBM).
CSV (Computer System Validation) in May 2016, conducted by Epitome Technologies. NAGESWAR RAO
Address: Odisha
Phone: + (91-799**-*****
Email: ************@*****.***
CAREER OBJECTIVE:
To have a challenging position within an organization, where my Technical, Analytical skills, Knowledge and Experience can be shared and enhanced. I strongly believe in sharing of experience with trained and developed state-of-the-art professional team.
WORK EXPERIENCE: Total 14 years of experience in IT Sun Pharmaceutical Laboratories Ltd, Manager-IT at Guwahati, Assam
Good experience on Global IT Incident (Across Sun pharma in Mar 2023) and recovery process,
Business Continuity Plan and Implementation of Network/Server high security & Data protection.
Blue screen error in end user systems across locations which is resulting frequent system restart due to global outage issue (July 2024).
Role and Responsibility: Department Head
Responsible for the Guwahati location OSD and NOSD plant.
Handling of IT-Operations and IT-Compliance.
To support the Budget, Capex/Opex planning, and resource management process for the IT department at the site’s.
Resource allocation for various need-based requirements.
Preparation and submission of the weekly and monthly MIS report.
Participation in the periodic review meeting, Weekly PD meeting and QRB meeting.
Responsible for the Audit response, QRB, IT QMS and IT Compliance.
To support regulatory, customer, or internal inspection with respect to IT Infra-related queries.
Responsible for the site IT-Infrastructure Management, Data Center, Site Infra Projects, people management and support on Computer System Validation activity.
To support IT infra for Servers, Data Backup and Networking at site.
Monitoring of Datacentre / Data Backup log / Storage Utilization / Server & Network utilization and Health Check-up.
Coordinate with Vendors, Services providers, or Business functions for resolution of any applications, IT services, or IT functional issues.
To review and approve the various documents.
Ensure adherence to organizations/site/department (IT) policies, guidelines, and procedures and ensure generation of adequate and accurate documentation.
Coordination with centralized IT Team & site users for implementation/rollout of centralized applications/projects.
Analyzing 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.
Training of business users on various applications during rollouts & on a need basis.
Local applications development, post-implementation support, and rollout in the site or other location (need basis).
Providing additional support and Guidance on system breakdown (Business applications/Server/Network/Manufacturing systems/Quality Systems). Project Support and Achievements:
QR code system implementation in OSD block,
Network security implementation to secure the (Business Data / IT network / Servers & Standalone systems Lab, Production & Manufacturing).
Project support for the new area expansion.
Ajanta Pharma Ltd, Asst. Manager (Bharuch, Gujarat) from 2021 to 2022 Role and Responsibility: Head of the Department, reporting to Sr. VP (Plant Head Operations)
Responsible for IT Operations, Compliance and Team management (Infra and CSV Team).
To support the Budget, Capex, Opex planning.
To carry out the PR and vendor bill payment in the SAP system.
Resource management process for IT department at site.
To support IT infra for servers, Data Backup and Networking/Firewall at site.
Monitoring of Datacentre / Data Backup log / Internet bandwidth utilization / NAS Storage / Storage Utilization / Server & Network utilization and Health Check-up.
Deploying the Firewall security policy, Domain policy and Local policy as per business requirements.
To support regulatory, customer or internal inspection with respect to IT Infra related quires.
Represent IT at site business forums, meetings.
To performing the administrative activity in LIMS, QMS, TRIMS, and GxP applications available in QC, Production, and Manufacturing equipment’s.
To preparation and revise the IT-SOPs and documentation.
To support on Computer System Validation as per GAMP-5 and V- module.
Responsible for the QMS (Incident, Change control, Deviation, CAPA).
Business continuity and Disaster recovery planning, Participate in the Self-Inspection.
Interacting with business stockholders to understanding the Business requirements & Project plan implementation at site.
Project works:
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 implementation the network connectivity in Production & Manufacturing equipment’s for Auto data backup configuration (Acronic backup solution). Key Achievements:
Faced 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 IT-CSV role and Single contact person to business stockholder.
Technical support to GxP servers and, GxP applications.
To monitor and deploy IT-Policy in GxP systems, Laboratory, production & manufacturing systems.
To manage and update the GxP-Inventory (Applications and, Hardware).
Supporting programming development team to develop in-house applications and in execution.
Preparation of IT-SOPs and documentation, GAP analysis, and audit preparation.
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.
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.
Project works are: -
SAP Sprint risk assessment.
Implementation of corporate network in between Production & Manufacturing PLC SCADA systems & other systems to configured Auto data backup schedule, Antivirus installation, 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 are:
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.
Monitoring and Technical support: AD, Antivirus, ERP Progen, HPLC, Standalone, RADOC and other Business applications.
Data backup configuration & monitoring and Disaster recovery planning.
Network firewall (Cyber room security) monitoring and implementation of different security policies, monitoring of bandwidth utilization, VPN connectivity to other locations, and security patches update.
To perform Infrastructure validation (CSV) and Managing of GxP applications.
Audit preparation and responsible for Audit and audit compliance.
Responsible to manage IT Inventory, Preparation of IT-SOPs & Documentation
To review cross functional department documents, URS, DQ, CC, CAPA, Deviation and SOP’s. Completed Projects: End - End
Track & Trace system implementation and validation.
ERP Macro vision system implementation and Validation with different modules.
Cloud base application for RA dept. to send Douser Documents to regulatory agency. Key Achievements: Zero observation from 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 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 time line, appreciated by Auditor and Company CEO, Lab HOD, IT GM for timely clear the audit observation points.
Audit faced: USFDA, Microsoft and other Externa agency audit. Accenture Solution Pvt Ltd. (Ahmedabad, Gujarat) IT-Operation Analyst 2015 to 2018 Zydus Cadila Healthcare Ltd., at Moraiya plant
Role and Responsibility: IT-CSV (SME) and Site IT-Incharge
Responsible for IT-compliance and to face Auditor.
Managing and monitoring of different servers (Backup server, HPLC, Standalone & Open LAB ECM (Enterprise Content Manager) server).
Responsible for Data center management and Reviewing of Data backup log.
Handling of FMS Team, IT-Facility management team of 20 members and Analysis daily calls.
Preparing of audit plan USFDA, WHO, DCGI Customer audit and Internal QA/CQA & External audit CQA.
Timely reporting on-going project and regular activity status to management.
IT-SOPs preparation and documentation.
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 laboratory system control policy to ensure 21 CFR part 11.
To perform software validation with Internal GLP Team and Service Engineer (IQ, OQ & PQ) and PRM challenge Test.
Responsible to fill SOP Annexure’s and verification of other IT registers.
Responsible to support Lab incident closer, identify the root cause, Vendor coordination and submitting IT-Investigation report to user dept.
Working projects are: End – End
To preparation of central IT SOPs and implementation at other Zydus locations.
Domain policy implementation in Laboratory systems at all Zydus site location. Key Achievements:
Champion Trophy award received from Accenture and Silver coin from Zydus Cadila.
USFDA audit thrice from 2016 to 2018 and Lachman Audit, Explained IT role and responsibility in Laboratory applications, IT-control on GxP systems and Data archival process.
Audit pass with zero observations, Good learning and experience to face audit. Accel-Frontline Ltd. System Admin (Mumbai) 2012 to 2015 Client: Export Import Bank of India (Head Office-Mumbai), and GroupMTech Role and Responsibility:
Different server managing and troubleshooting of server hardware related issues and collecting diagnostic report from respect OEM tools (IBM/Dell/HP servers), Coordinate with the vendor to fix the issues.
Managing and monitoring of AD, Exchange server, POP3, File & Print server management, WSUS server for windows patches update in servers & client’s system.
Remote support to other location.
Familiar with different data backup tool, AVAMAR, Symantec and Cobian.
Managing of IT Infrastructure and User base application support, Like: Share Point, Finacle Treasury, NDS Server, (e-Token) Digital Signature, Exim-HRMS, Exim- Intranet, Dark Management, spark messenger, COE-Notes.
Managing of different network Firewall (Palo Alto/Sonic WALL and Cisco)
Switch and Router configuration, Backup taken, managing and monitoring.
Network Cable crimping & other Network related issue addressing.
VC Room setup, managing Polycom device, VC-Wireless Presentation sharing and Tele present connectivity.
Key Achievements: Best work performance award from Mumbai religion. Geekay Infotech, Reliance Infotech at Mumbai
Sr. Technical Support Engineer from 2011 to 2012
Desktop Support at Reliance InfoTech Mumbai location. EDUCATION:
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
PERSONAL DETAILS:
Father Name : Ghanshyam Pedini
Mother Name : Pedini Kurei
Date of Birth : 31 Aug 1985
Languages Knowns : English, Hindi, Oriya, Telugu, Marathi & Guajarati.
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: Mumbai
Date: Jun 2024
Nageswar Rao
Contact this candidate