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IT Operatrions and Infrastracture, IT-CSV and Compliance

Location:
India
Salary:
16
Posted:
March 25, 2023

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Resume:

COVER LETTER

To,

The Respected sir

Sub: Application for a suitable position for IT-Operations, IT-Compliance, IT-CSV, IT-Audit and Infrastructure management role.

Dear Sir,

I am, Nageswar Rao. I have completed my MBA in IT. I have 12 years of experience in IT. presently working as a Manager-IT at “Sun Pharmaceutical Laboratories Ltd” at Guwahati, Assam location. I have good knowledge and experience in following key areas:

Handling of IT- Operations and Compliance.

Participate in the Self-Inspection as an IT-Inspector.

IT-CSV (Computer System Validation), Vendor audit, IT-Auditee & Team management.

Managing of IT-Infrastructure, Business continuity plan, DR and Data centre management.

Managing of AD, Group policy, Antivirus, Backup server (familiar with Veritas, Veeam agent and other), IT-Assets, SAP, LIMS, ERP, application servers and Database servers.

Managing of network firewall, Cable crimping, and different network devices configuration, familiar with

(Fort iGATE, Palo Alto, and Cisco).

Preparation of IT-SOPs, URS and documentation.

Experience in QMS process, Incident, CAPA, Deviation, Data Integrity, Change control etc.

Experience to face regulatory Audit and Audit compliance: - US-FDA, WHO, DCGI, MHRA, External agency audit, and internal CQA audits.

Microsoft audit and IT-Asset audits.

Qualification & Validation: - GAP assessment, risk assessment, and performing of Computer System Validation (CSV) as per GAMP 5 Category and V-Module, 21 CFR part 11 ER & ES. Experience to work in business projects End to End: - MES Werum Pas-X with Sarala, Track & Trace system implementation, ERP progen system Implementation and validation, Migration of Empower 3 & 3.7, Open Lab 2.5, Chromeleon 7.2, EWS (Early warning system) in laboratory applications with EY team, LIMS upgradation, SAP risk Assessment, cloud base solution implementation, Centralize IT policy implementation in Production & manufacturing equipment’s and supporting to in-house programing development team, etc. Procurement of new Hardware and software, networking cable laying with vendor, Vendor audit (FAT), facilitated the IT support, GxP assessment, performing of CSV, applications administrative activity. Familiar with various Pharma applications:

SAP, ERP progen, LIMS, QMS system, DCS (Document management systems), HR-Success Factor, Training system, Chromeleon 6.8/7.2, Empower 3.0 & 3.7, Agilent Open Lab 2.5, Lab-Solutions, TOC-L, Malvern particle sizer, DSC, KF, LBPC, Vitec, Stability chamber, Track & Trace system with Rfxcel & Trace link, cloud base applications Abe-cube, NKP 2D Barcode system, LIS NOx View, Glatt, FETTE, CIA Mattel detector, MMD, DMS, LCMS, different IT applications, etc.

I have attained a strong knowledge in the fundamentals of quality and IT compliance systems and realized their practical applications through my industrial experience. Over the last 7 years of my pharma Professional experience, my key areas of involvement lied in the areas of IT-CSV, IT-Compliance, Facilitated the IT-support, Project work and Team management.

Qualification & validation of equipment/instruments, CSV with experience in FDA (GxP, 21 CFR Part 11), EU Annex 11, GAMP 5, QMS, Data Integrity, eCompliance and other regulatory compliance. My Experience has not only enabled me to attain technical skills and realize their practical viability, but also Fetched me sound organizational skills, interpersonal skills, professionalism and problem-solving Capabilities. Please review my resume in consideration for my application. I look forward to hearing a positive response from you.

Thank you for your time and consideration.

Sincerely,

Nageswar Rao

Microsoft 2008 Certification, Read hat Linux and CCNA 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: Orissa

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

Email: adv4yn@r.postjobfree.com

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.

PROFESSIONAL EXPERIENCE: Interest to work in multi functions role in IT Total 12 years of experience in IT,

WORK EXPERIENCE: Manager - IT at Sun Pharmaceutical Laboratories Ltd (Guwahati, Assam) Role and Responsibility:

Responsible for IT-Operations and Compliance (OSD & NOSD).

To support the IT infra for servers, User infra, and Networking at the site.

To support regulatory, customer, or internal inspection with respect to IT Infra-related queries.

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

Represent IT at site business forums, meetings, etc.

To support the Budget, Capex/Opex planning, and resource management process for the IT department at the site.

Coordinate with centralized IT Team, Vendors, Services providers, or Business functions for resolution of any applications, IT services, or IT functional issues.

Training of business users on various applications during rollouts & on a need basis.

Represent IT in any regulatory, Customer, or Inspection and coordinate with site IT or centralized Team to provide desired inputs/information.

Supervise, Support, and Manage the location IT Team of SPLL.

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

Administration role for all GxP applications, OSD, NOSD, QC, Micro block, and Eng. PLC-SCADA systems and Global applications are being used at the plant.

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.

Preparation and submission of the weekly, and monthly report, MIS, and Project review slides and participation in periodic reviews.

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

Local applications development, post-implementation support, and rollout in the site or other location (need basis).

To prepare, Review and approve the various documents.

Technical owner and CS infrastructure Lead for Quality & Manufacturing systems.

Resource allocation for various need-based requirements.

Additionally, to support Mfg. Computer Systems and Quality applications. Asst. Manager (Bharuch, Gujarat) from 2021 to 2022 Role and Responsibility: Head of the Department, reporting to VP (Plant Head Operations)

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

To support the Budget, Capex/Opex planning and resource management process for IT department at site.

To support the IT infra for servers, User infra and Networking at site.

Monitoring and deploying the Firewall security policy, Domain policy, and Local policy.

Monitoring data backup log, NAS storage, Storage space utilization, and Server health check-up.

To support regulatory, customer or internal inspection with respect to IT Infra related quires.

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

Represent IT at site business forums, meetings, Interacting with business stockholders for new requirements and implementation at site.

To preparation and revise the IT-SOPs and documentation.

Performing the administrative activity in LIMS, QMS, TRIMS, and GxP applications - QC, Production, and Manufacturing equipment’s.

To performing the 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.

To carry out the PR and vendor bill payment in the SAP system. 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 network connectivity in Production & Manufacturing systems and configured Auto data backup, Clients are joint with Domain server, 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 from 2015 to 2018

Client: Zydus Cadila Healthcare Ltd., 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. Mumbai

System admin, from 2012 to 2015

Client: Export Import Bank of India (Head Office-Mumbai), 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:

MC-ITP 2008

Microsoft 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:

Nageswar Rao



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