Summary
Overview
Work History
Education
Skills
Accomplishments
Technical Competency & Regulatory Exposure
Leadership & Collaboration Skills
Timeline
Generic

Rashmi B G

Senior Quality Assurance & CSV Specialist

Summary

Senior Quality Assurance & CSV professional with over 13 years of experience in pharmaceutical manufacturing, specialising in insulin downstream processes and water systems. Demonstrated expertise in Good Manufacturing Practices (GMP), quality systems (TrackWise, LIMS, SAP), CAPA, risk assessment, and compliance with global regulatory standards (FDA 21 CFR Part 11, EU Annex 11, TGA). Proven track record managing computer system validations (CSV), batch disposition, deviation investigations, and continuous improvement initiatives. Strong collaborator with excellent communication and cross-functional leadership skills, consistently recognised for performance excellence, audit readiness, and documentation quality.

Overview

15
15
years of professional experience
2010
2010
years of post-secondary education

Work History

Associate Manager

Biocon Biologics Limited
01.2018 - Current
  • Led audit readiness programs, achieving 100% internal QA audit scores.
  • Successfully passed 3+ external inspections (EU/US FDA) with zero critical observations.
  • Spearheaded automated QA checklists and templates; improved SOP compliance turnaround by 40%.
  • Drove deviation closure efficiency by 30% through proactive CAPA management in TrackWise.
  • Delivered validation for 10+ clinical systems and applications (21 CFR Part 11, Annex 11).
  • Led OpEx projects to improve throughput and TAT in the insulin facility; applied Lean Six Sigma (5S, DMAIC, VSM).
  • Improved OEE by 15% via Kaizen and root cause projects.
  • Represented Biocon in global audits (USFDA, CDSCO, TGA, MHRA, etc.); demonstrated FDA compliance.
  • Coordinated preventive maintenance documentation and QMS reviews.
  • Reviewed trend reports and supported proactive quality improvement actions.

Quality Assurance Lead / Subject Matter Expert

Biocon Biologics Limited
01.2015 - 12.2017
  • Handled complex investigations for OOS, OOAL, OOS, OOAC, and OOT, and market complaints in DS manufacturing.
  • Managed product quality and market complaints, including root cause, resolution, and trend analysis.
  • Led CAPA management lifecycle – evaluation, documentation, and effectiveness reviews.
  • Managed CSV projects in compliance with 21 CFR Part 11, GAMP 5, and Annex 11.
  • Participated as an SME in batch disposition meetings, SOP reviews, and training sessions.
  • Contributed to process risk assessments and validation-based risk assessments.
  • Participated in Management Review Meetings as the SPOC for deviation and CAPA discussions.

Senior Associate / Quality Assurance Executive

Biocon Biologics Limited
01.2011 - 12.2014
  • Responsible for failure investigation and root cause analysis in insulin downstream manufacturing activities and water systems.
  • Performed Gemba walks during deviations and incidents; conducted cause-impact assessments.
  • Coordinated with cross-functional teams for investigation report preparation.
  • Handled cleaning, validation, and process validation in insulin drug substance manufacturing.
  • Participated in batch disposition management and documentation compliance.
  • Attended internal audits and contributed to EHS documentation and internal audit preparation (AIM, HIRA).

Education

BE - Biotechnology

SJCE
Karnataka (India)
12-2010

Skills

TOOLS & SYSTEMS

  • TrackWise (Event & CAPA Management)
  • SAP (Batch Disposition & Quality Systems)
  • LIMS (Laboratory Information Management)
  • DMS (Document Management System)
  • Veeva (QMS & Compliance)
  • Windows 10

TECHNICAL SKILLS

  • GMP Compliance & Quality Systems
  • Computer System Validation (CSV) – FDA 21 CFR Part 11, EU Annex 11

Accomplishments

  • Achieved 100% audit readiness by leading internal QA reviews and implementing corrective actions aligned with GxP and ISO 9001 standards.
  • Reduced deviation closure time by 30% through proactive CAPA management and process optimization in TrackWise.
  • Led validation of 10+ clinical systems and applications under FDA 21 CFR part 11 and Annex 11 compliance guidelines.

Technical Competency & Regulatory Exposure

Technical Competencies

  • Quality systems: TrackWise, SAP SuccessFactors, LIMS, DMS, CSV, QMS.
  • Investigations & compliance: Deviation handling, CAPA, OOS/OOT/OOAC investigations.
  • Process validation: Cleaning validation, water system qualification, 21 CFR Part 11, Annex 11.
  • Risk & change control: Risk assessments, change control processes, audit readiness.
  • Manufacturing knowledge: Insulin downstream processes, sanitization/ozonisation/CIP, GDP/GMP compliance.
  • Regulatory alignment: Experienced in FDA, TGA, MHRA, ANVISA expectations.


Audit & Regulatory Inspection Experience

  • Successfully participated in audits conducted by: USFDA, CDSCO, COFEPRIS, EMEA, ANVISA, DCGI, MHRA, TGA, Russian Regulatory, PMDA (Pharmaceuticals & Medical Devices).

Leadership & Collaboration Skills

  • Proven ability to monitor and drive timely closure of QMS elements, supporting on-schedule batch releases.
  • Strong interpersonal and cross-functional collaboration skills across quality, manufacturing, and regulatory teams.
  • Proactive issue resolution and data-driven decision-making in dynamic environments.
  • Recognised for performance excellence; awarded ‘Outstanding Performer’ in two consecutive appraisals.
  • Adaptive and quick to master new systems, tools, and regulatory frameworks.

Timeline

Associate Manager

Biocon Biologics Limited
01.2018 - Current

Quality Assurance Lead / Subject Matter Expert

Biocon Biologics Limited
01.2015 - 12.2017

Senior Associate / Quality Assurance Executive

Biocon Biologics Limited
01.2011 - 12.2014

BE - Biotechnology

SJCE

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Rashmi B GSenior Quality Assurance & CSV Specialist