Summary
Overview
Work History
Education
Skills
Audit Faced
Instruments Used
Personal Information
Timeline
Generic
ARKAPRABHA PANDE

ARKAPRABHA PANDE

Kolkata

Summary

Dynamic Associate Consultant with extensive experience at Tata Consultancy Services in Chromatography Data Systems administration and compliance. Proven ability in troubleshooting and enhancing instrument connectivity while ensuring regulatory adherence. Skilled in Empower 3 and cross-functional collaboration, driving quality improvements and operational efficiency in laboratory environments.

Overview

13
13
years of professional experience

Work History

Associate Consultant

Tata Consultancy Services
Kolkata
06.2024 - 09.2025
  • Chromatography Data Systems (CDS) Administration Waters Empower & Agilent OpenLab: Possess a deep understanding of Empower Enterprise architecture, including installation, configuration, and troubleshooting of both Empower and OpenLab applications.
  • Instrument Connectivity: Hands-on experience in configuring and troubleshooting hardware and connectivity issues for a variety of instruments, including Waters, Agilent, Thermo. This includes resolving functional issues within the CDS related to data acquisition and processing.
  • Compliance & Audit: Audit compliance, ensuring all IT operations in Various Lab Applications, Managed User and Project Management, Monthly Empower audit trial review, Data Backup and Storage management and project activities adhere to regulatory and internal standards.
  • Cross-Functional Collaboration: Experience collaborating with business and IT stakeholders to analyze requirements, perform system changes, validate functionality, and ensure thorough documentation.

Senior Executive-QC

Synokem Lifesciences Pvt Ltd.
Haridwar
10.2022 - 04.2024
  • Conducted quality control activities, including raw material inspection and product testing using HPLC and GC.
  • Ensured compliance with ICH Guidelines through rigorous chemical testing and material verification.
  • Developed and implemented quality control procedures to uphold high manufacturing standards.
  • Collaborated with cross-functional teams to resolve quality issues and enhance process efficiency.
  • Maintained accurate records of quality activities, such as test results and inspection reports.
  • Reviewed periodic audit trials and backed up QC instrument data for document management.

Executive-QC

Fresenius Kabi Oncology Limited
Kalyani-West Bengal
10.2018 - 10.2022
  • Planning for Finished and Stability section, monitoring CDS activities.
  • Electronic Review of data generated in laboratory and performing Sign off-2.
  • Performed Method transfer, Method Verification and CSV Activities.
  • Ensuring laboratory compliance and actively participating in Internal, CQA and Regulatory audits.
  • Review of investigation reports and Analytical investigations and implementation of CAPA.
  • Method and Template creation and EDR in Empower.
  • Root cause analysis of OOT, OOS Samples & troubleshooting.
  • Performed Laboratory Analysis through LIMS Application.

Associate-QC

Dr. Reddy’s Laboratories
Hyderabad
07.2015 - 09.2018
  • Performed GLP activities and routine Laboratory Analysis through LIMS Application.
  • Stability chamber Management.

QC Executive

Torrent Pharmaceuticals Ltd
Sikkim Plant
08.2014 - 06.2015

Chemist in QC

Acme Pharmaceuticals
Sikkim Plant
08.2012 - 08.2014
  • Company Overview: (a unit of Zydus)
  • (a unit of Zydus)

Education

M.Sc - Organic Chemistry

Guru Ghasidas Central University
01.2012

B.Sc - Chemistry Hons.

University of Calcutta
01.2010

Skills

  • QTest
  • Caliber DMS
  • Caliber LIMS
  • Trackwise
  • Empower 3
  • Chromeleon 68,72

Audit Faced

  • USFDA
  • MHRA
  • ANVISA
  • TGA
  • MCC
  • About 25 Customer Audits (like Cipla, Mylan, MicroLab, Biocon, Akums, Zydus, SunPharma, Mankind)

Instruments Used

  • GC (Agilent-Autosampler-7890A,7890B,6890N and Headspace-7697A, G1888)
  • UPLC-Waters (Acquity & Arc)
  • HPLC-Agilent (1200,1220,1260, Infinity series)
  • KF Auto Titrator (Tiamo)
  • Dissolution Test apparatus (Electrolab)
  • UV (Shimadzu 1800, 1700)
  • IR (Shimadzu Prestige-21)

Personal Information

Available: Immediately Available to join

Timeline

Associate Consultant

Tata Consultancy Services
06.2024 - 09.2025

Senior Executive-QC

Synokem Lifesciences Pvt Ltd.
10.2022 - 04.2024

Executive-QC

Fresenius Kabi Oncology Limited
10.2018 - 10.2022

Associate-QC

Dr. Reddy’s Laboratories
07.2015 - 09.2018

QC Executive

Torrent Pharmaceuticals Ltd
08.2014 - 06.2015

Chemist in QC

Acme Pharmaceuticals
08.2012 - 08.2014

M.Sc - Organic Chemistry

Guru Ghasidas Central University

B.Sc - Chemistry Hons.

University of Calcutta
ARKAPRABHA PANDE