Gaurav Tanwar
IT Executive
Baddi,HP
Summary
Professional Experience
IT Professional with 6.5+ years of experience in Information Technology, specializing in Computer System Validation (CSV), IT Compliance, and GxP systems management within the pharmaceutical industry. Experienced in managing IT validation activities, electronic logbook systems, backup and disaster recovery solutions, and quality management systems. Skilled in working with platforms such as ValGenesis, TrackWise, Veeam Backup & Replication, and HITPHAMS while ensuring compliance with regulatory and GxP requirements.
Having professional experience since April 2019 in the field of Information Technology, currently associated with Alkem Laboratories Ltd.. Responsible for supporting IT compliance and Computer System Validation activities, guiding and coordinating with IT team members to ensure proper implementation, validation, and maintenance of GxP computerized systems in accordance with regulatory standards.
Overview
7
7
years of professional experience
Work History
IT EXECUTIVE
Alkem Laboratories
Baddi, India
03.2025 - Current
Professional Experience
- Working as IT Executive, responsible for IT Qualification and Validation activities using the ValGenesis application.
- Creating and managing electronic logbook formats (ELOGs) using HITPHAMS software.
- Handling QMS-related activities, including deviations, change controls, and CAPA management through TrackWise.
- Managing and resolving IT incidents and investigations, ensuring compliance with regulatory and internal quality standards.
- Preparing and maintaining planned maintenance schedules, system backup and restoration verification, and inventory management for GxP systems.
- Successfully completed Server Room Modification, including installation and qualification of Vertiv SmartRack infrastructure.
- Performed upgrade of Veeam Backup & Replication to enhance backup performance and reliability.
- Migrated all backup jobs from file-level backup to image-level backup for GxP systems using Veeam Backup & Replication to improve disaster recovery capability.
- Implemented backup storage architecture using Scale-Out Backup Repository (SOBR) with performance tier on HPE StoreOnce, capacity tier using Amazon S3, and archive tier on Amazon S3 Glacier for optimized backup storage management.
- Completed upgrade and qualification of HITPHAMS for ELOGS implementation.
CORP. IT EXECUTIVE
AKUMS DRUGS & PHARMACEUTICALS LTD
HARIDWAR, UTTRAKHAND
12.2023 - 03.2025
- Computer system validation of all QC and Production Equipment and Enterprises application.
- Administrative GxP Activity and Compliance Implementation of IT Procedures (SOPs) for streamlining IT operations.
- Monitor IT Backup activity, IT Audit, and Verification of System control as per 21 CFR Part 11 Requirements.
- Implementation and Maintain of IT compliance in Quality control and Production area.
- Preparation of IT SOPs (Standard Operating Procedures), CAPA, Deviations, Investigations and all documentation for the project activity which includes GxP Assessment and System Classification Checklist, System Level Risk Assessment, User Requirement Specification, Functional Requirement Specification, Functional Level Risk Assessment, Configuration Specification Document, Qualification, Project Validation Plan, Checklist (21 CFR Part 11)
IT EXECUTIVE
TORRENT PHARMACEUTICALS LTD
BADDI, HIMACHAL PRADESH
07.2023 - 12.2023
- Monthly manual backup taken from all manufacturing machines.
- User Management Regarding GxP Application in Manufacturing.
- Maintain Log Books as appropriate for all the GxP IT systems as per SOP's.
IT OFFICER
PANACEA BIOTEC LTD
BADDI, HIMACHAL PRADESH
07.2022 - 07.2023
- Preparation of document for CSV execution.
- Preparation of SOPs for IT
- Phasing WHO Geneva Audit for Vaccine Plant.
- CSV Qualification of Tracktrace, Access control system
- Investigation from an IT perspective in Production and QC.
- Handling all QMS activity Related to the IT Department.
- Preventive Maintenance and Windows control verification every month as per SOP.
- New SOP Preparation for Data Backup and Preventive Maintenance.
- Implementation of DOCUZEN, EDUZEN and QUALZEN
- User Management in GxP Application in QC & Manufacturing.
- Execution of IQ, OQ and PQ protocols in the computerized system.
- Qualification of EVLMS for Qualification of instrument and software.
- New Backup Tool implementation and Qualification of Veritas System Recovery.
- User management in TOC V, TOC L, UV probe, ICDAS, Chromeleon.
- Date and Time Synchronization in QC Balance, Disso and standalone instrument etc.
- Monthly folder Creation in chromeleon and TOC.
IT OFFICER
INDOCO REMEDIES LTD
BADDI, HIMACHAL PRADESH
08.2021 - 07.2022
- Brief Knowledge of computerized system validation test cases.
- Execution of IQ, OQ and PQ protocols.
- Change Control, Deviation and CAPA-related activities through Trackwise.
- Annually Requalification of GxP system.
- Data Restoration and verification of GxP annual basis
- Verify all User Group Privileges in the GxP system E.g Lab solution, LABx and Chromeleon software.
- Maintain all QC equipment and GxP Instruments.
- User Management in Domain and GxP Applications in QC & Manufacturing.
- Backup Monitoring daily through backup software and manual backup taken from the client database.
- Working on Chromeleon for audit trails and sequence locking.
- Folder Creation on chromeleon Chromatography Data System software every month.
- Time synchronization in all GxP systems every month.
- Network restructuring in all areas.
- Date and Time sync in stability chamber and weighing balance.
QC SUPPORT ENGINEER
SYSNET GLOBAL TECHNOLOGIES Working for DR. REDDYS LABORATORIES
BADDI, HIMACHAL PRADESH
04.2019 - 08.2021
- To assist users with technical support of desktop computers, laptops, printers, IP Phones, data Cards, applications, and related technology. Support includes specification, installation, and Testing of computer systems and peripherals within established standards.
- To act as an immediate troubleshooting technician with application software and operating systems to diagnose and resolve unique, non-recurring problems.
- Respond to incident tickets on the Techease tool and provide updates in a fixed timely manner.
- GxP ticket closing through SAP in Solution Manager.
- Works with vendor support contacts to resolve technical problems with Desktop computing equipment and software.
- Troubleshoot issues in OS, Network connectivity and Antivirus clients.
- Provide End-to-end IT support: Phone support and Remote tools.
- Coordinating with vendors for any issues.
- To act as IT administrator for GxP application in the absence of the IT Manager.
- Maintain Log Books as appropriate for all the GxP IT systems as per SOP's.
- Maintain all QC types of equipment and GxP Instruments.
- Working on System Restoration every year through Acronis Software.
- User Management and Monthly Project Creation in Empower 3.
- Helping users within businesses to properly utilize their computers.
- Working on Local Area Network.
- Knowledge about LAN Centralization and Video Conferencing.
- Manage Network Storage Device.
- Create and Maintain HMI Machine Backup.
- Create and Maintain Day-to-day IT Log Book.
- Worked on network Issues due to LAN.
- Perform IQ/PQ/Operational qualification as per computerized system validation (CSV).
- Provide training to users on IT procedures. (IMAC, Shared folder access, User ID Creation/Modification/Deletion etc.)
- Monthly manual backup taken from all manufacturing machines.
- Monthly Project creations in QC GxP systems every month.
- Providing Support in User Management Regarding GxP Applications in QC & Manufacturing.
- Installation and Operational Qualification for Host Intrusion Prevention System (HIPS) in GxP systems.
Education
Electronics and Communication Engineering
MAHARAJA AGRASEN UNIVERSITY
BADDI, HIMACHAL PRADESH07-2018
12th - undefined
GOVT. SR. SEC SCHOOL (HP BOARD DHARAMSHALA)
BAROTIWALA, HIMACHAL PRADESH03-2014
10th (MATRIC) - undefined
DOON PUBLIC SCHOOL (HP BOARD DHARAMSHALA)
BAROTIWALA, HIMACHAL PRADESH03-2012
Skills
- Strong Communication
- Team Management
- Process Improvement
- IT Tools
- Application management
- Digital transformation
- IT risk management
- IT service management
- Team collaboration
- Documentation management
- IT resource use
- IT infrastructure management
Interests
Drawing, Travelling, Chess
LANGUAGES
English
Hindi
Punjabi
Timeline
IT EXECUTIVE
Alkem Laboratories
03.2025 - Current
CORP. IT EXECUTIVE
AKUMS DRUGS & PHARMACEUTICALS LTD
12.2023 - 03.2025
IT EXECUTIVE
TORRENT PHARMACEUTICALS LTD
07.2023 - 12.2023
IT OFFICER
PANACEA BIOTEC LTD
07.2022 - 07.2023
IT OFFICER
INDOCO REMEDIES LTD
08.2021 - 07.2022
QC SUPPORT ENGINEER
SYSNET GLOBAL TECHNOLOGIES Working for DR. REDDYS LABORATORIES
04.2019 - 08.2021
12th - undefined
GOVT. SR. SEC SCHOOL (HP BOARD DHARAMSHALA)
10th (MATRIC) - undefined
DOON PUBLIC SCHOOL (HP BOARD DHARAMSHALA)
Electronics and Communication Engineering
MAHARAJA AGRASEN UNIVERSITY
Drawing, Travelling
Pencil sketching and exploring new destinations through travel.