Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Timeline
Generic

SABARINATH DHANDAPANI

Dublin,Dublin

Summary

Experienced QA professional with a strong background in upstream and downstream processes of biopharmaceutical and chemical synthesis. Solid grasp of bioprocess engineering principles. Skilled in adhering to GMP, cGMP, GDP, and regulatory guidelines. Keen eye for quality systems, audit trail review, and audit preparedness.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Senior Executive, QA

Biocon Biologics Limited
01.2022 - 08.2023
  • Company Overview: Largest biopharmaceutical company in India
  • Led QMS processes comprising change control, deviations, and CAPAs using Trackwise (Human Insulin & Insulin Glargine drug substance).
  • Performed Risk assessments on Audit trail review and Line/Area clearance requirements.
  • Supervised a team of 5 in audit trail reviews and compliance with 21 CFR part 11 requirements for all the computerized systems.
  • Prepared/reviewed annual product quality reports for drug substances, SOPs, (master and executed) batch manufacturing (downstream) and packaging & dispatch activity. Involved and approved drug substance labels, intermediate and drug substance release.
  • Accomplished 50% of the Lean Six Sigma Green Belt project, reducing batch record complexity thereby improving TAT of BMR review by about 25%.
  • Actively involved in the implementation of EDMS at site.
  • Ensured readiness for regulatory audits, including FDA (as a runner), through documentation and compliance.

QA Executive

Lupin Limited
05.2020 - 12.2021
  • Company Overview: Leading global biopharmaceutical company in India
  • Managed upstream and downstream processes for mammalian and microbial manufacturing and also led QMS activities (eQMS).
  • Conducted continuous process verification and improved yield trends using Minitab and actively involved in preparation of APQRs for drug substances.
  • Actively involved in the master cell bank preparation and inventory, cleaning & process validation, technology transfers for new product introduction (NPI).
  • Review and approval of (master & executed) BMRs, packing & dispatch activity, intermediate drug substance release and SOPs (EDMS).

Production Executive

Anthem Biosciences Pvt Ltd
01.2018 - 04.2020
  • Company Overview: Contract Research Development Organization
  • Authored and reviewed master batch records, SOPs, equipment qualification documents and QMS activities.
  • Optimized equipment selection and calculated OEE for chemical synthesis processes.
  • Prepared for regulatory audits, ensuring adherence to FDA requirements.

Graduate Engineer Trainee

Ultramarine and Pigments Ltd
09.2016 - 09.2017
  • Designed a surfactant manufacturing plant of 3 tons/batch and calculated bill of materials.
  • Implemented cost-effective sulphate removal process improvements in effluent treatment (lab scale).
  • Monitored project progress to ensure compliance with design and safety standards.

Education

Master of Science - Bioprocess Engineering

Dublin City University
Dublin
11.2024

Bachelor of Technology - Chemical Engineering

AC College of Technology, Anna University
04.2015

Skills

  • Trackwise, Minitab, SAP, EDMS, eQMS, eLog and Microsoft Office Suite
  • Knowledge on lean six sigma
  • Stakeholder communication, Team management, Attention to detail and Multitasking Abilities

Accomplishments

    • "Go Getter" – Led audit trail review team for regulatory compliance at Biocon Biologics Limited.

Certification

  • Six Sigma and the Organization (Advanced) obtained from Coursera (September 2024) https://coursera.org/verify/33VO6VXPWY9T

Timeline

Senior Executive, QA

Biocon Biologics Limited
01.2022 - 08.2023

QA Executive

Lupin Limited
05.2020 - 12.2021

Production Executive

Anthem Biosciences Pvt Ltd
01.2018 - 04.2020

Graduate Engineer Trainee

Ultramarine and Pigments Ltd
09.2016 - 09.2017

Bachelor of Technology - Chemical Engineering

AC College of Technology, Anna University

Master of Science - Bioprocess Engineering

Dublin City University

Similar Profiles

CREATE PROFILE
SABARINATH DHANDAPANI