Summary
Overview
Work History
Education
Skills
Languages
Personal Information
Roles And Responsibilities
Audits Faced
Completed Projects
Timeline
Generic

Bhavesh Savaliya

Summary

Professional with over 9+ years of CSV-IT exp. in pharmaceutical industry. To utilize extensive technical knowledge of Computer System Validation (CSV) methodologies to execute and manage validation activities for complex IT systems, ensuring uncompromised data quality and regulatory adherence To confirm compliance with data integrity elements/requirements and ensure all computerized systems are aligned with ALCOA+ principles

Overview

10
10
years of professional experience

Work History

Sr. Executive – IT-QA

Intas Pharmaceuticals Limited
09.2023 - Current
  • Responsible for preparation and executing computer system validation deliverables (URS, IIA, VP, FS, CS, FRA, IQ, OQ, PQ test script, RTM, VSR, etc.) for new and enhanced systems of Laboratory Softwares like LabHawk software (Excel sheet validation), Labsolutions software, Chromeleon software, Omnis software, Caliber LIMS, Tiamo Software, ECM & CDS Data Management Software, TOC Control.
  • Performing the periodic review of software’s based on the software criticality.
  • Participate in risk assessment activity performed for computer systems, allocate mitigation plans accordingly, and ensure compliance.
  • Working experience in QMS such as (Deviation, Change Control, CAPA and Investigation) for CSV/IT Compliance activity.
  • Performed GAP Assessment of Laboratory software related to computer system validation document related GAPs.
  • Windows Group Policy Implementation in instrument PC.
  • Prepare and review of standard operating procedures related to information technology (IT) policies, and confirm that these SOPs and policies have been reviewed and revised periodically.
  • Support during Audit and Audit Compliance Activities
  • Facing of Regulatory Audit like USFDA, TGA and Customer audits
  • Performed Audit of CSV service provider (ICP Industrial automation Pvt. Ltd., Clean room validation solution)
  • Support & Review External vendor qualification documents
  • User Account Management Activities in QC/MFG Equipment/Instruments
  • Backup and restoration Activities in QC/MFG Equipment/Instruments

IT Executive-Compliance

Unison pharmaceutical Pvt. Ltd.
01.2022 - 09.2023

IT Executive

Torrent Pharmaceutical Limited
Bhat
12.2019 - 01.2022

Creative Infotech Solutions Pvt. Ltd.
Ankleshwar
09.2017 - 12.2019

Assistant validation Engineer

Kevin Technologies Pvt. Ltd.
Ahmedabad
12.2016 - 09.2017

Omega instrumentation and controls
Vadodara
03.2016 - 12.2016

Education

B.E. - Electrical and Electronics engineering

Shree Saraswati Education Sansthan Rajpur
01.2015

Diploma - Electronics and communication engineering

G.E.C. Gandhinagar
01.2012

S. S. C - undefined

Vidhyanagar Higher Secondary School
01.2007

Skills

  • Technical & Functional
  • Planning
  • QMS Software
  • Training management
  • MS-OFFICE
  • Time Management
  • Investigation

Languages

English
Hindi
Gujarati

Personal Information

  • Hobbies: Travelling, Watching Cricket, Hearing Songs
  • Date of Birth: July 25, 1991
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Married

Roles And Responsibilities

  • Responsible for preparation and executing computer system validation deliverables (URS, IIA, VP, FS, CS, FRA, IQ, OQ, PQ test script, RTM, VSR, etc.) for new and enhanced systems of Laboratory Softwares.
  • Performing the periodic review of software’s based on the software criticality.
  • Participate in risk assessment activity performed for computer systems, allocate mitigation plans accordingly, and ensure compliance.
  • Working experience in QMS such as (Deviation, Change Control, CAPA and Investigation) for CSV/IT Compliance activity.
  • Performed GAP Assessment of Laboratory software related to computer system validation document related GAPs.
  • Windows Group Policy Implementation in instrument PC.
  • Prepare and review of standard operating procedures related to information technology (IT) policies.
  • Support during Audit and Audit Compliance Activities.
  • Facing of Regulatory Audit like USFDA, TGA and Customer audits.
  • Performed Audit of CSV service provider.
  • Support & Review External vendor qualification documents.
  • User Account Management Activities in QC/MFG Equipment/Instruments.
  • Backup and restoration Activities in QC/MFG Equipment/Instruments.

Audits Faced

  • USFDA
  • EMEA
  • TGA
  • WHO
  • Customer & Consultant Audits

Completed Projects

  • Sun Pharmaceutical Industries Limited.(Halol)
  • RAKS PHARMACEUTICAL Pvt. Ltd.(Dahej)
  • E.I.D.-PARRY (INDIA) LIMITED (Tamil Nadu)
  • Thermolab Scientific Equipments (Ahmedabad)
  • Wockhardt Limited (Ankleshwar)
  • Wockhardt Limited (Daman)
  • Alembic pharmaceutical Limited (Panelav)
  • Sterile-gene life science Pvt. Ltd. (Puducherry)
  • Zydus Cadila Pharmaceutical Limited (Moraiya)
  • Sun Pharmaceutical Industries Limited.(Dahej)
  • Torrent pharmaceutical limited (Chhatral)
  • Fourrts (India) Laboratory Pvt. Ltd. (Chennai)
  • Cipla Pharmaceutical Limited (Sikkim)

Timeline

Sr. Executive – IT-QA

Intas Pharmaceuticals Limited
09.2023 - Current

IT Executive-Compliance

Unison pharmaceutical Pvt. Ltd.
01.2022 - 09.2023

IT Executive

Torrent Pharmaceutical Limited
12.2019 - 01.2022

Creative Infotech Solutions Pvt. Ltd.
09.2017 - 12.2019

Assistant validation Engineer

Kevin Technologies Pvt. Ltd.
12.2016 - 09.2017

Omega instrumentation and controls
03.2016 - 12.2016

B.E. - Electrical and Electronics engineering

Shree Saraswati Education Sansthan Rajpur

Diploma - Electronics and communication engineering

G.E.C. Gandhinagar

S. S. C - undefined

Vidhyanagar Higher Secondary School

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Bhavesh Savaliya