Chetan Khaire
Pune
Summary
Dynamic LIMS consultant with a proven track record at Infosys Ltd, excelling in Master Data Management. Adept at enhancing operational efficiency and delivering impactful training. Skilled in Labvantage, Caliber, Labware, and Sample Manager LIMS, along with SAP S4 Hana QM module knowledge. I thrive in collaborative environments, driving successful project outcomes while ensuring compliance with industry standards.
Overview
12
12
years of professional experience
Work History
LIMS Consultant
INFOSYS LTD
Pune
08.2021 - Current
- Collaborated with clients to identify business challenges and refine relevant data for deliverables.
- Evaluated existing systems against industry best practices to enhance operational efficiency.
- Gathered requirements and prepared Functional Specification document for Master Data Migration project.
- Reviewed and verified consumables and test methods in LIMS, ensuring compliance with GxP standards.
- Collaborate with the development team to ensure successful product delivery.
- Developed and delivered training materials and documentation for LIMS users.
- Defined project scope, objectives, and deliverables in collaboration with stakeholders.
- Acted as Functional Trainer, facilitating knowledge sharing and maintaining knowledge process repository.
- Verified documentation to ensure compliance with processing and GMP requirements.
- Developed test methods, consumables, and local master data in Labvantage.
Atem Software Solutions Pvt. Ltd
12.2020 - 08.2021
- Company Overview: Deputed to Infosys Ltd
- Experience in Building Test methods, consumables and local master data in Labvantage.
- As a functional expert, responsible for gathering requirements and preparation of Functional Specification document for Master Data Migration (MDM) project.
- Experience in Review and verification of Consumables and Test methods in LIMS and prepare documents as per GxP.
- Working as Functional Trainer and responsible for Knowledge sharing, maintaining and updating knowledge process repository throughout the project.
- To verify and ensure up to date documentation pertaining to processing and GMP requirements.
- Deputed to Infosys Ltd
Master Data Analyst
Intertek India Pvt. Ltd.
Mumbai
12.2019 - 12.2020
- Company Overview: Mumbai
- To verify and ensure up to date documentation pertaining to processing and GMP requirements.
- Participate and support for computer system validation.
- Creating and configuring master data in Thermo Fischer Sample Manager (Analysis, specifications, and other static data).
- Receive and resolve operational support requests pertaining to LIMS master data.
- Troubleshoot problems associated with configuration and validation.
- Responsible for planning and conducting training related to LIMS application.
- Mumbai
Sr. Officer CQA
Brill Pharma Pvt. Ltd.
Mumbai
12.2017 - 08.2019
- Company Overview: Mumbai
- Performed computer system validation as per regulatory guidelines such as GAMP 5, 21 CFR part 11 and Annex 11.
- Prepared User Requirement Specification (URS) for new customization and configuration of software.
- Prepared and execute protocols for Installation Qualification, Operational Qualification, and performance Qualification.
- Prepared and ensured compliance of SOP.
- Responsible for Initiate and closure of Change control, CAPA and deviation in QMS.
- Preparation and review of master data in Caliber LIMS as per specification.
- Preparation of stability protocols in LIMS.
- Responsible for Master Data Creation in SAP and maintain master data for SAP-LIMS interface.
- Responsible for creation/modification and termination of access for users.
- Responsible for SAP-LIMS interface.
- Creation of new material, customer, and vendor codes in SAP.
- Mumbai
Sr. Officer QC
Ajanta Pharma Pvt. Ltd.
08.2016 - 12.2017
- Involved in the implementation of SAP as a core team member of QM module.
- Responsible for Master Data Creation in SAP and maintain master data for SAP-LIMS interface.
- Responsible for trouble shoot workflow related issues.
- Responsible for creation/modification and termination of access for users.
- Preparation of master data for analysis protocol in LIMS as per specification.
- Preparation and verification of item code wise test plan in Caliber LIMS for Finished products, Raw material, Stability Management and packing material.
- Participate and support computer system validation.
Officer QC
CIPLA Pharmaceuticals Ltd.
03.2015 - 08.2016
- Preparation and verification Master Data in LIMS for Finished products, Raw material, Stability Management and packing material.
- Performed analysis of Primary, secondary, and tertiary packing materials.
- Performed SAP Operations to verify and change Inspections lots.
Assistant Chemical Analyser
FORENSIC SCIENCE LAB
08.2013 - 09.2014
- Analysis of various types of crime cases such as poisons and narcotics.
- Analysis of petroleum products, explosive materials by laboratory methods.
- Acquired extensive exposure in working on sophisticated instruments.
Education
MSc - Organic Chemistry
Modern College
Pune07-2013
BSc - Chemistry
C.T. Bora College
Shirur07-2011
HSC -
New English School
Parner07-2008
SSC -
Shri Chhatrapati Shivaji Maharaj Vidyalay
Lonimavala06-2006
Skills
- Labvantage
- Caliber
- Sample Manager
- Labware
- Computer system validation
- SAP-QM
- LIMS configuration
- Master data management
Disclaimer
I hereby declare that the above written information is true and completed to the best of my knowledge.
Languages
- English
- Hindi
- Marathi
Hobbies and Interests
- Reading
- Travelling
- Playing Outdoor games
Personal Information
Date of Birth: 03/19/91
Timeline
LIMS Consultant
INFOSYS LTD
08.2021 - Current
Atem Software Solutions Pvt. Ltd
12.2020 - 08.2021
Master Data Analyst
Intertek India Pvt. Ltd.
12.2019 - 12.2020
Sr. Officer CQA
Brill Pharma Pvt. Ltd.
12.2017 - 08.2019
Sr. Officer QC
Ajanta Pharma Pvt. Ltd.
08.2016 - 12.2017
Officer QC
CIPLA Pharmaceuticals Ltd.
03.2015 - 08.2016
Assistant Chemical Analyser
FORENSIC SCIENCE LAB
08.2013 - 09.2014
MSc - Organic Chemistry
Modern College
BSc - Chemistry
C.T. Bora College
HSC -
New English School
SSC -
Shri Chhatrapati Shivaji Maharaj Vidyalay
Similar Profiles
Sudhakar KatikireddySudhakar Katikireddy
Lead Consultant at Infosys LtdLead Consultant at Infosys Ltd
SAIKRISHNA HARISAIKRISHNA HARI
Principal Consultant at Infosys LtdPrincipal Consultant at Infosys Ltd
SHRIYA GANGULYSHRIYA GANGULY
Senior System Engineer at Infosys LtdSenior System Engineer at Infosys Ltd
Mohammed Shoeb Ur RahmanMohammed Shoeb Ur Rahman
Senior Technical Process Executive at Infosys LtdSenior Technical Process Executive at Infosys Ltd
Shreyas KedarShreyas Kedar
IT Development Team Lead at Transimpact Pvt LtdIT Development Team Lead at Transimpact Pvt Ltd