Gaurang Thakkar

is looking for freelance projects. 🔎

Vorstandsmitglied, SAP /S4HANA / LIMS / Lab Informatics / AI Integration & Automation, VYOM Infotec GmbH
Mannheim, Deutschland

Fähigkeiten und Kenntnisse

Change Control
Electronic Lab Notebooks
Chromatography
ICH-GCP
Empower
Artificial Intelligence (AI)
Clinical Data Management
Information Technology
ERP Implementations
Bioanalysis
Clinical Development
IT Operations
GCP
Bioinformatics
Clinical Research
IT Service Management
GLP
Business Process
Clinical Trial Management System (CTMS)
Laboratory Information Management System (LIMS)
CDS
GMP
Clinical Trials
LC-MS
Good Clinical Practice (GCP)
LES
CRO
Good Laboratory Practice (GLP)
CRO Management
Life Sciences
Medical Writing
High-Performance Liquid Chromatography (HPLC)
Data Management
Lifesciences
Pharmaceutical Industry
HPLC
LIMS
Structural Bioinformatics
Pharmaceutics
U.S. Title 21 CFR Part 11 Regulation
Pharmacovigilance
Quality Assurance
Validation
Regulatory Affairs
Regulatory Compliance
Regulatory Submissions
SAP Quality Management (QM)
Sop

Werdegang

Berufserfahrung von Gaurang Thakkar

  • Bis heute 4 Jahre und 8 Monate, seit Okt. 2021

    SAP /S4HANA / LIMS / Lab Informatics / AI Integration & Automation

    VYOM Infotec GmbH

    Managing Director, VYOM Infotec GmbH, Germany

  • Bis heute 4 Jahre und 8 Monate, seit Okt. 2021

    Managing Director @ VYOM Infotec GmbH

    VYOM Infotec GmbH

    Germany-Based IT Partner for Clints | Managing Director @ VYOM Infotec GmbH

  • 1 Jahr und 4 Monate, Dez. 2022 - März 2024

    LABVANTAGE LIMS Consultant

    BASF

    LABVANTAGE LIMS Services and Support for Connectivity LABs and Onboarding LABs of BASF Different Sites.

  • 1 Jahr und 4 Monate, Aug. 2021 - Nov. 2022

    Business Analyst

    Novo Nordisk

    LABVANTAGE LIMS Connectivity with LAB Instruments

  • 2 Jahre und 7 Monate, Jan. 2019 - Juli 2021

    Global Business Process Manager

    Merck Group

    Implementation of Global LIMS (LabVantage LIMS 8.4) and It's Connected Systems for multiple laboratories (Quality Control, Biotech and R&D) for Different Sites.

  • 5 Monate, Sep. 2018 - Jan. 2019

    SAP-LIMS Business Specialist (EMEA)

    LabVantage Solutions, Inc

    Worked as a Business Analyst at LabVantage Solutions. LabVantage offers a comprehensive portfolio of products and services for the laboratory, including LIMS (Laboratory Information Management), quality electronic laboratory notebook (ELN), laboratory execution system (LES), and business intelligence. I worked on a couple of projects to find the right solution on implementation of LabVantage LIMS and its interfaces (SAP Interface, CDS- Empower Interface, SDMS, MES and Instrument Interface) for international

  • 2 Jahre und 11 Monate, Okt. 2015 - Aug. 2018

    Lab Informatics Consultant

    Bayer Business Services

    • LabVantage LIMS Test Lead and Support. • 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 (including LIMS, SDMS, Empower, SAP QM, Lab Instruments) with LabVantage LIMS.

  • 1 Jahr und 2 Monate, Aug. 2014 - Sep. 2015

    CSV Consultant - Regulatory Compliance Specialist

    Allergan

    • Manage Service Delivery and Client Management from Compliance 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) • 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 clie

  • 10 Monate, Okt. 2013 - Juli 2014

    Validation and Application Support Specialist

    GSK

    • 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, Oracle Database and Infrastructure Management • Manual Rebooting of servers, Back up & Restore Process for all Template & consolidated Servers • Responsible for providing solutions to Pharma clients and project teams in the space of IT Compliance, Computer System Validation (CSV) and Quality Assurance. • 24*7 s

  • 1 Jahr und 5 Monate, Mai 2012 - Sep. 2013

    Bio-IT LIMS Administrator

    Alkem Laboratories Ltd.

    • Overall Watson LIMS Administration & Application Support. • Overall responsibility for handling of all studies and method validation as well as interpretation, analysis, documentation, and reporting of results through LIMS. • Responsible for all kind of configuration, System admin and Lab Admin related functionalities. • Development and Implementation of Barcode label-printer for Sample handling, sample tracking, Instruments and other modules in LIMS • Establishment of interface for report generation t

  • 4 Jahre und 10 Monate, Juli 2007 - Apr. 2012

    Bio-Analyst cum Watson LIMS Expert

    Veeda Clinical Research

    • Bioanalytical Method Development for various Pharmaceutical Investigational products using HPLC and LC-MS/MS • Validation of the developed Bioanalytical Methods and Sample Analysis using Validated Methods • Calibration and maintenance of equipments (Pipette, PH meter, Balance, Centrifuge) • Worked for Product from Thermo, as Watson LIMS Operator for all modules • Instruments handled: LC-MS/MS: MDS Sciex API 2000, MDS Sciex API 3000, MDS Sciex API 4000 HPLC and Shimadzu-LCVP series along with U.V, Fluoresc

Ausbildung von Gaurang Thakkar

  • 2007 - 2008

    M. Phil

    Gujarat University

  • 2005 - 2007

    M. Sc

    Hem.NorthGujarat University

  • 2000 - 2002

    H.S.C

    G.S.E.B

  • 1999 - 2000

    S.S.C

    G.S.E.B

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