Summary
Overview
Work History
Education
Skills
Software
Timeline
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Anilkumar Gubbala

Deputy Manger Quality Assurance
Banglore

Summary

Accomplished Deputy Manager/Manager – QA at Biocon Biologics Limited
A results-oriented and highly skilled quality assurance professional with comprehensive experience across API, Sterile Drug Products (DP), Drug Substances (DS), Vaccines, and Monoclonal Antibodies (MAbs) manufacturing. Expertise in change control, CAPA, and regulatory compliance within highly regulated environments. Proven track record in enhancing audit readiness, ensuring GMP compliance, and supporting successful regulatory submissions. Adept at leading quality assurance initiatives, managing cross-functional teams, and driving continuous improvements in product quality and operational efficiency. Demonstrated ability to improve key performance indicators (KPIs) through strategic oversight, effective risk management, and robust process optimization.

Overview

14
14
years of professional experience
3
3
Languages

Work History

Deputy Manager- QA

Biocon Biologics Limited
06.2021 - Current
  • Change Management: Review, categorization, approval, tracking, and closure of changes in TrackWise.
  • CAPA Management: Approval, tracking, and closure of Corrective and Preventive Actions (CAPAs) in TrackWise.
  • Deviation Management: Categorization, review of investigations, and closure of deviations in TrackWise.
  • Analyze data and metrics to identify trends and areas for improvement within quality systems and business processes.
  • Present Key Performance Indicator (KPI) data during Management Review Meetings to support decision-making and continuous improvement.
  • Support audit and compliance teams, ensuring audit preparedness and contributing to successful audit outcomes.
  • Maintain a healthy set of site KPIs and implement strategies for ongoing quality improvements.
  • Ensure team members are appropriately qualified and trained to perform activities per company policies and procedures.
  • Coordinate with regulatory agencies and partners to address concerns and successfully execute site-level modifications

Quality Systems Professional

Sanofi Health Care India Pvt Limited
01.2015 - 06.2021
  • Provide clearance for sterile activities at different stages of batch manufacturing for drug substance vaccine manufacturing.
  • Ensure that the manufacturing facility is audit-ready, with proper shop floor supervision in place, and GMP compliance upheld.
  • Review and approve documentation such as MFRs, BMRs, SOPs, Process Validation Protocol, Cleaning Validation Protocol, and Experiment Study Protocol/Report.
  • Prepare the Annual Product Review of Drug Substance.
  • Conduct regular audits to maintain adherence to established quality management system requirements.

Sr Officer

Indian Immunological Limited
08.2013 - 01.2015
  • Responsible for giving line clearance for bulk manufacturing & Filling (DS & DP) Vaccine.
  • Review of BMRs & analytical reports for Batch release.
  • Preparation and review of Annual Product Quality Review (APQRs) for Drug Product.

Sr Chemist

Raks Pharma Pvt Ltd
01.2011 - 08.2013
  • Distribution and issuance of Quality Documents SOPS, BMRS, STPS, Specifications.
  • Reviewing the Batch Manufacturing Records and Analytical Reports for releasing the batch for distribution
  • Giving line clearances for Finished Api & Intermediates
  • Coordination in vendor management

Education

Master of Science - Biochemistry

Andhra University
Visakhapatnam
07.2006 - 2008.07

Bachelor of Science - Biotechnology, Biochemistry & Chemistry

Andhra University
Visakhapatnam, India
06.2003 - 2006.07

Skills

Change control, CAPA, Deviation & Risk Management

Software

Track wise

Ms office

Adobe Acrobat

SAP

SharePoint

Timeline

Deputy Manager- QA

Biocon Biologics Limited
06.2021 - Current

Quality Systems Professional

Sanofi Health Care India Pvt Limited
01.2015 - 06.2021

Sr Officer

Indian Immunological Limited
08.2013 - 01.2015

Sr Chemist

Raks Pharma Pvt Ltd
01.2011 - 08.2013

Master of Science - Biochemistry

Andhra University
07.2006 - 2008.07

Bachelor of Science - Biotechnology, Biochemistry & Chemistry

Andhra University
06.2003 - 2006.07

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Anilkumar GubbalaDeputy Manger Quality Assurance