Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Otherdeliverables
Auditmanagement
Personal Information
Otherdeliverables
Auditmanagement
Personal Information
Hi, I’m

YASODA DEVI CHOUDHARY

Visakhapatnam

Summary

Talented Manager with expert team leadership, planning, and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.

Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.

Overview

20
years of professional experience

Work History

Dr. Reddy’s Laboratories Ltd.

Team lead - QA
2015.07 - Current (9 years & 2 months)

Job overview

  • Audit & Compliance
  • Audit Management: Acting as Principle coordinator during execution of external audits i.e., Regulatory Inspections &Customer Audits.
  • Preparation of compliance reports for Customer Audit / Regulatory Inspection Reports timely.
  • Conduct audits at DRL internal departments as per established audit schedule to identify gaps and improvement opportunities in existing systems.
  • Preparation of site for all time audit readiness.
  • QMS activities:
  • Responsible to review of investigation of major Incidents occurred during manufacturing process.
  • Responsible to review investigation of Out of specifications.
  • Responsible to investigate of Return goods, Customer complaints.
  • Responsible to review and approve of annual review of the products as per the schedule.
  • Preparation of Quality Metrics for Management Review.
  • Handling team of 10 members for contemporaneous data review at manufacturing facilities.
  • Impart cGMP Trainings to employees at site.
  • Supporting to review of DMFs and Amendments prepared by Regulatory Affairs department for submissions.
  • Key Achievements:
  • Received Appreciation award from Management for outstanding support for US FDA warning letter compliance audit.
  • Successful completion of regulatory inspection namely US FDA, KFDA, Health Canada, EDQM, TGA - Australia, PMDA-Japan, COFEPRIS (Mexican Health Authority), EMA-Greece, Russian GMP & CDSCO for EU Written confirmation.
  • Appreciation from management for US FDA Warning letter remediation tasks (DI assessment, OOS Review, Product Quality Assessment, Lot Concurrence etc., by third party consultants i.e., Lachhman, Gintegra, Validant and QCG).

Laurus Laboratories Pvt. Ltd.

Sr. Executive – Quality Assurance
2008.07 - 2015.07 (7 years)

Job overview

Avara Laboratories Pvt. Limited

Executive - Quality Assurance
2006.02 - 2008.06 (2 years & 4 months)

Job overview

Saraca Laboratories Limited

Executive - Quality Assurance
2004.06 - 2006.02 (1 year & 8 months)

Job overview

Education

Acharya Nagarjuna University

Master of Science (M.Sc.) from Chemistry
01.2006

University Overview

Percentage: 62%

Acharya Nagarjuna University

Bachelor of Science (B.Sc.) from Industrial Chemistry
01.2004

University Overview

Percentage: 69%

Skills

  • Making better utilization of available resources. Adaptability to different environments and quick learning capabilities. Quick strategic problem solver & Decision Making Quality Mindset Effective Communication Openness to New Ideas
  • Microsoft Office, Internet skills, SAP system.
  • Knowledge of GMP Analytical/Testing Instrumentation Knowledge Knowledge of Manufacturing Equipment and Processes Knowledge of Validation & Qualification Regulatory Knowledge
  • Regulatory Compliance

Accomplishments

Accomplishments
  • Received Appreciation award from Management for outstanding support for US FDA warning letter compliance audit.
  • Playing a key role for the successful completion of regulatory inspection namely US FDA, KFDA, Health Canada, EDQM, TGA - Australia, PMDA-Japan, COFEPRIS (Mexican Health Authority), EMA-Greece, Russian GMP & CDSCO for EU Written confirmation.
  • Appreciation from management for US FDA Warning letter remediation tasks (DI assessment, OOS Review, Product Quality Assessment, Lot Concurrence etc., by third party consultants i.e., Lachhman, Gintegra, Validant and QCG).

Languages

English, Hindi and Telugu

Otherdeliverables

Otherdeliverables
  • Validations (Process / Cleaning / Analytical Method).
  • Technology Transfer of new products.
  • Vendor Qualification Qualifications (Equipment, Instrument, Utilities).
  • Key Quality Management Systems Preparation & review of Departmental Procedures Preparation of Site Master File and Validation Master Plan Evaluation of Change Controls Investigation of major Deviations,
  • Out of Specification (OOS) and Out Of Trend (OOT) test results, Market Complaints, Return Goods and Recall Monitoring the enforcement of CAPA system.
  • Preparation and review of Annual Products Quality Review (APQR) reports.
  • Release of APIs and Saleable Intermediates to Market. Document Control

Auditmanagement

Auditmanagement

Faced  below regulatory inspections and customer audits in front line 

  • US FDA - 6 times
  • Health Canada - 3 times
  • EDQM- 1 time
  • KFDA - 1 time
  • COFEPRIS (Mexican Health Authority)- 2 times
  • PMDA, Japan- 2 times
  • EMA - 1 time
  • Russian GMP - 1 Time
  • Customer audits - ~ 400

Personal Information

Personal Information
  • Date of Birth: 11/07/1983
  • Marital Status: Married
  • Contact number: 9392029194/9100787331

Otherdeliverables

Otherdeliverables
  • Validations (Process / Cleaning / Analytical Method).
  • Technology Transfer of new products.
  • Vendor Qualification Qualifications (Equipment, Instrument, Utilities).
  • Key Quality Management Systems Preparation & review of Departmental Procedures Preparation of Site Master File and Validation Master Plan Evaluation of Change Controls Investigation of major Deviations,
  • Out of Specification (OOS) and Out Of Trend (OOT) test results, Market Complaints, Return Goods and Recall Monitoring the enforcement of CAPA system.
  • Preparation and review of Annual Products Quality Review (APQR) reports.
  • Release of APIs and Saleable Intermediates to Market. Document Control

Auditmanagement

Auditmanagement

Faced  below regulatory inspections and customer audits in front line 

  • US FDA - 6 times
  • Health Canada - 3 times
  • EDQM- 1 time
  • KFDA - 1 time
  • COFEPRIS (Mexican Health Authority)- 2 times
  • PMDA, Japan- 2 times
  • EMA - 1 time
  • Russian GMP - 1 Time
  • Customer audits - ~ 400

Personal Information

Personal Information
  • Date of Birth: 11/07/1983
  • Marital Status: Married

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YASODA DEVI CHOUDHARY