• LabVantage LIMS Business Consultant for Implementing LIMS in different LABs like QC/Analytical/R&D/AP etc.
• Day to day requirement gathering with Business Team from Different LABs having different workflow
• Transferring Requirement to functional spec and complete implementation life cycle
• Master data creation Support including calculations
• Master data transfer via DFD/CTT from Legacy system
• SAP Master data support - creation/transfer
• Implementation, planning, and execution of the LabVantage LIMS project in a GXP environment
• Have very good knowledge on laboratory business processes workflow and corresponding system configuration
• Implementation of the different LIMS modules
• Excellent knowledge in LIMS and e-system deployment in validation environment
• Design and Implementation of solutions with the help of LIMS Developer by handling configuration part Independently

• LabVantage LIMS Business Consultant for connecting LIMS with SAP and all other laboratory equipment/software which includes Empower-CDS, SDMS, MES, SAP-QM, Magellan, M9-Sievers, HIAC, Shimadzu, OPC etc. Implementation and Support
• Expertise on Risk Assessment, Data Integrity, Software Validation and Audit trail
• Implementation, planning, and execution of the LabVantage LIMS project in a GMP environment
• Have very good knowledge on laboratory business processes workflow and corresponding system configuration
• Implementation of the different LIMS modules including validations of computerized systems and data integrity assessments according to the valid specifications
• Excellent knowledge in LIMS and e-system deployment in validation environment
• Design and Implementation of solutions with the help of LIMS Developer by handling configuration part Independently

• Lab Informatics Business Consultant for LIMS, Empower-CDS, SDMS, MES, SAP-QM, Instrument Interface, AERA, Binocs, Discoverant, Tableau and other connected e-system Implementation and Support
• Have very good knowledge on laboratory business processes workflow and corresponding system configuration
• Implemented Global LIMS (LabVantage LIMS 8.4) and Its Connected Systems for multiple laboratories (Quality Control, Biotech and R&D) for Different Sites.
  
• Expertise on Risk Assessment, Data Integrity, Software Validation and Audit trail
• Overall responsible for implementing and supporting end to end functionality and Business Flow for LabVantage LIMS to index and cross-referenced by QA and compliance
• Responsible for Implementing and testing all different kind of Interfaces (Like Empower-CDS, SDMS, MES, SAP-QM, Instrument Interface, AERA, Binocs, Discoverant, Tableau and other connected e-system with LabVantage LIMS.
• Responsible for implementing global requirements and local needs to be fulfilled in accordance with the Change Control Process lifecycle
• Responsible for assuring compliance to applicable guidance and regulations in the Global LIMS implementations
• Have clear understanding on User Requirement Specification and Functional Requirement Specification based on business processes\ Flow
• Responsible for providing solutions to Pharma and Biotech sites and project teams in the space of LIMS and connected tools along with Instruments
• Have sound knowledge for validation and testing of LIMS implementation which includes (Unit Testing, Module Testing, Configuration Testing, System Testing, Integration Testing, UAT Testing and Regression Testing)

• LabVantage LIMS Techno-Functional Consultant for LIMS Implementation and Support.
• Responsible for Implementing and testing all different kind of Interfaces (Like SAP, Empower, SDMS-New genesis,
• Worked for 3 different projects of LABVANTAGE LIMS Implementation in diverse areas like Pharma, Flavoring and Food Industry.
  
• Excellent knowledge in LIMS and e-system deployment in validation environment (experience in global deployment of LIMS in pharma multi-national companies).
• Overall responsible for implementing and supporting end to end functionality and Business Flow for LabVantage LIMS to index and cross-referenced by QA and compliance.
• Responsible for implementing global requirements and local needs to be fulfilled in accordance with the Change Control Process lifecycle.
• Responsible for assuring compliance to applicable guidance and regulations in the Global LIMS implementations.
• Have clear understanding on User Requirement Specification and Functional Requirement Specification based on business processes\ Flow.
• Have very good knowledge on laboratory business processes workflow and corresponding system configuration.
• Responsible for providing solutions to Pharma clients and project teams in the space of IT Compliance, Computer System Validation (CSV) and Quality Assurance.
• Managing Service Delivery and Client Management from Business Analyst, Solution Engineer and Compliance Prospective.
• Have sound knowledge for validation and testing of LIMS implementation which includes (Unit Testing, Module Testing, Configuration Testing, System Testing, Integration Testing, UAT Testing and Regression Testing).
• Responsible to generate and review the software Validation Dockets (DQ, IO, OQ and PQ) and routine dockets

• Lab Informatics Techno-Functional Consultant for LIMS Implementation and Support of E-Systems
• Overall responsible for implementing and supporting end to end functionality and Business Flow for Lab Informatics related systems to index and cross-referenced by QA and compliance to Data Integrity
• Responsible for Implementing and testing all different kind of Interfaces (Like SAP, Empower, SDMS-New genesis, LIMSLink, COMMCONNECT etc.) with LabVantage LIMS
• Manage Service Delivery and Client Management including Global Support. Have clear understanding on User Requirement Specification and Functional Requirement Specification based on business processes\ Flow
• Have very good knowledge on laboratory business processes and understanding on day-to-day business workflow
• Worked as Test Lead for LIMS implementation which includes (Unit Testing, Module Testing, Configuration Testing, System Testing, Integration Testing, UAT Testing and Regression Testing)

• Manage Service Delivery and Client Management from Compliance and Data Integrity Prospective
• End to End Data Center Migration for Client which include applications (LabWare LIMS, SAP, SAS etc...) and servers (Unix, Windows, Linux ? Physical and Virtual both)
• As a part of Security Tools Validation
• QualysGuard
• MacAfee SIEM
• AlgoSec Firewall Analyzer
• CyberArc
  
• Service Now and Solar winds Monitoring
• Assist in troubleshooting post implementation issues
• Training to different technical towers for compliance related activity and regulatory (21 CFR Part 11, HIPPA, SOX)
• Responsible for providing solutions to Pharma clients and project teams in the space of IT Compliance, Computer System Validation (CSV) and Quality Assurance
• Responsible for setting up the service and defining the operational model

• Supported Pharma Manufacturing Application (LAB MANAGER LIMS and LABWARE LIMS) ? 26 Sites UK, US & Malaysia
• Maintaining Template & consolidated Servers
• Daily monitoring of server health check
• As a part of Infrastructure Management
• Account Management (server as well as Application) New Account creation, Modification, Activation, Deactivation
• Managing printer queues & Batch Jobs
• Archiving & De-archiving
• Pre-& Post checks of Backup
• Oracle Database Monitoring
• Manual Rebooting of servers
• Back up & Restore Process for all Template & consolidated Servers
• Argen and Adhock Reporting Tool
• 24*7 support with the help of 10 members core support Team

• Overall Watson LIMS Administration and Novell ERP Administration
• Also looking after for VMS (Volunteer Management System), Caliber LIMS, Analyst Software, Mass Lynx Software and SAS Software
• Overall responsibility for handling of all studies and method validation as well as interpretation, analysis, documentation, and reporting of results through LIMS
• To configure User Roles, Security Assignments and new user creation
• To create and finalize the study design in LIMS as per the clinical protocol
• Responsible to Design templates for study specific & sponsor/Client specific Barcode label
• Sample handling and sample tracking through LIMS
• To perform regression and to accept or reject the batch as per the criteria mentioned in respective SOPs
• To establish the atomization of report generation through LIMS for:
• To transfer the final concentration data to WinNonlin or SAS for PK analysis
• To update the final concentration profile to Clients
• Responsible for result locking, study locking and electronic study archiving of the completed study
• Responsible to update the lab management on progress of projects/studies
• Responsible for archiving and e-archiving of the completed study and other raw data
• To resolve the queries related to DMS from QA, Sponsors and any regulatory body
  
• To recognize and implement the LIMS features as per the current requirement and to perform software validation as per the requirement
• To guide and supervise the group members for trouble shooting and smooth operation of the activities.
• Responsible for training and up gradation of group members and maintaining the training records

Additional Job Responsibilities:

• Responsible to establish and implement the procedures for the automation of system in BE Center
• To establish and implement the procedure for software validation, spreadsheet validation in lab
• Responsible for writing and revising the in-house SOPs as per need in Bioanalytical applications.
• To ensure all applicable GLP regulations are followed.
• Responsible to generate and review the Instrument Validation Dockets (DQ, IO, OQ and PQ) and routine calibration dockets
• Responsible to generate and review the software Validation Dockets (DQ, IO, OQ and PQ) and routine dockets

• Bioanalytical Method Development for various Pharmaceutical Investigational products using HPLC and LC-MS/MS
• Validation of the developed Bioanalytical Methods
  
• Sample Analysis using Validated Methods
• Calibration and maintenance of equipments
• Maintaining the equipment log(s)
• Preparation and review of SOPs, Method SOPs, Protocols, Plans and Reports
• Reply to relevant BQM & QA queries in co-ordination with team members & BQM respectively
• Responsible to update the Sr. group leader on progress of projects on daily basis
• Responsible for training coordination and upgradation of group members and maintaining the training records

Instrument handled:

• LC-MS/MS:
  • MDS Sciex API 2000
  • MDS Sciex API 3000
  • MDS Sciex API 4000
• HPLC:
  • Shimadzu-LCVP series along with U.V, Fluorescence and PDA Detector

• Bioanalytical Method Development for various Pharmaceutical Investigational products using HPLC and LC-MS/MS
• Validation of the developed Bioanalytical Methods
  
• Sample Analysis using Validated Methods
• Calibration and maintenance of equipments
• Maintaining the equipment log(s)
• Preparation and review of SOPs, Method SOPs, Protocols, Plans and Reports
• Reply to relevant BQM & QA queries in co-ordination with team members & BQM respectively
• Responsible to update the Sr. group leader on progress of projects on daily basis
• Responsible for training coordination and upgradation of group members and maintaining the training records

Instrument handled:

• LC-MS/MS:
  • MDS Sciex API 2000
  • MDS Sciex API 3000
  • MDS Sciex API 4000
• HPLC:
  • Shimadz?u-LCVP series along with U.V, Fluorescence and PDA Detector