Overview
Work History
Timeline
Generic
Open To Work

DEEKSHA S

Bangalore

Overview

4
4
years of professional experience

Work History

QC EXECUTIVE-DOCUMENTATION, QMS & ELOG

Biocon Biologics Pvt. Ltd.
Bangalore
06.2024 - Current
  • Prepare, review and maintain GMP documents including SOPs, Wis, logbooks and controlled forms ensuring accuracy, completeness and compliance.
  • Handle Quality Management System documentation for Deviations, CAPAs and Change Controls ensuring timely investigation and closure.
  • Support internal, customer and regulatory audits (USFDA, MHRA, EU GMP) by ensuring audit readiness and retrieval of required documents.
  • Actively involved in electronic Logbook (elog) implementation-process mapping, user training, validation and system rollout in QC laboratories.
  • Ensure compliance with cGMP, Data Integrity (ALCOA+), GDP and internal quality SOPs.
  • Work closely with QA, Manufacturing, Validation, IT and QC teams for process improvement and compliance excellence.
  • Preparation of analytical specifications for raw materials, intermediates and finished products by referring to pharmacopoeias including USP, EP, BP, IP and regulatory guidelines.
  • Ensure specification governance, periodic review and revision as per change control process.

QC ANALYST - IN-PROCESS SECTION

Biocon Biologics Pvt. Ltd.
Bangalore
07.2023 - 06.2024
  • Performed in-process analytical testing using pH meter, Osmolality analyzer and HPLC.
  • Ensured compliance with GMP, GLP and Data Integrity requirements in all activities.
  • Maintained laboratory records, instrument logbooks and batch documentation.
  • Supported troubleshooting and investigations for OOS/OOT results.

QC ANALYST - STABILITY SECTION

Biocon Biologics Pvt. Ltd.
Bangalore
05.2022 - 07.2023
  • Executed stability studies as per approved protocols and testing schedules.
  • Performed analytical testing using HPLC, pH and Osmolality methods.
  • Maintained stability data, trends, reports and documentation in compliance with GMP.
  • Assisted in investigations and contributed to process improvement initiatives.

Timeline

QC EXECUTIVE-DOCUMENTATION, QMS & ELOG

Biocon Biologics Pvt. Ltd.
06.2024 - Current

QC ANALYST - IN-PROCESS SECTION

Biocon Biologics Pvt. Ltd.
07.2023 - 06.2024

QC ANALYST - STABILITY SECTION

Biocon Biologics Pvt. Ltd.
05.2022 - 07.2023

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DEEKSHA S