Summary
Overview
Work History
Education
Skills
Timeline
Certification
AUDIT & COMPLIANCE EXPERIENCE
Generic
ANANTH KUMAR THASOJU

ANANTH KUMAR THASOJU

Pharmaceutical Quality Lead
Hyderabad

Summary

Quality Control leader with 27 years of experience in pharmaceutical manufacturing. Expertise in API, raw materials, stability studies, and regulatory compliance, with exposure to global audits by US FDA, WHO, ISO, PMDA, and COFEPRIS. Skilled in laboratory operations, method validation, and cross-functional coordination, driving quality and compliance in high-stakes environments.

Overview

1
1
Language
27
27
years of professional experience
4
4
Certificates

Work History

Senior Team Leader – Quality Control

Dr. Reddy’s Laboratories Ltd.
03.1999 - 03.2026
  • Lead quality control operations for raw materials, in-process samples, intermediates, and finished products.
  • Ensure timely testing and release/rejection decisions based on specifications.
  • Conduct and oversee OOS, OOT, and lab incident, or deviation investigations.
  • Maintain strict adherence to GLP, SOPs, and regulatory requirements.
  • Drive cross-functional coordination with R&D, production, RA, QA, and external labs.
  • Prepare and review daily/monthly QC reports, Certificates of Analysis, and compliance documentation to ensure regulatory adherence.
  • Led UV method validation and recovery factor studies across plant products, ensuring compliance with quality standards, and improving product reliability.
  • Played a key role in successful regulatory audits (U.S. FDA, WHO, ISO, EDQM, PMDA, COFEPRIS).
  • Manage instrument calibration's and preventive maintenance schedules.
  • Strengthened documentation practices by implementing error-free online documentation systems, enhancing accuracy, and accessibility.
  • Demonstrated leadership by guiding teams in quality initiatives.

*Previous Role Progression (Internal Growth)*

  • Assistant Manager – Managed API, RM, regulatory, dispatches, marketing samples, and CoA activities.
  • Junior Manager – Focused on finished product analysis, regulatory testing, and stability studies.
  • Senior Executive – Handled calibrations, working standards, and advanced instrumentation (GC, HPLC, XRD).
  • Executive – Managed in-process analysis and validation activities.
  • HPLC & GC: Waters, Shimadzu, Agilent (Empower-3, LC Solutions, ChemStation)
  • FTIR: Shimadzu, Perkin-Elmer.
  • UV Spectrophotometer: Shimadzu, Lambda Series.
  • Other QC Instruments: XRD, DSC, polarimeter.
  • Developed and implemented strategic plans to improve product quality and compliance standards.
  • Mentored junior team members, fostering a culture of continuous improvement and knowledge sharing.
  • Coordinated with regulatory bodies to ensure adherence to industry standards and safety regulations.
  • Reduced operational costs through effective budget management and cost control measures.
  • Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
  • Analyzed operational data to identify trends, driving informed decision-making for process enhancements.
  • Led cross-functional teams to optimize production workflows and enhance operational efficiency.
  • Analyzed performance metrics to identify trends, driving strategic initiatives for resource optimization.
  • Mentored junior team members, providing guidance and support to enhance their career progression.
  • Successfully managed budgets and allocated resources to maximize productivity and profitability.
  • Trained personnel in equipment maintenance and enforced participation in exercises focused on developing key skills.
  • Established performance goals for employees and provided feedback on methods for reaching those milestones.
  • Managed senior-level personnel working in marketing and sales capacities.

Education

B.Sc. - Botany, Zoology, Chemistry

Osmania University
Hyderabad, India
03-1998

Skills

Regulatory Compliance

Method Validations

Deviations/OOS/OOT

MS Office LIMS & SAP

GLP & Audit Compliance

Quality Control lead

Timeline

LIMS

04-2016

Millipore "Sample Preparation and water purification solutions'' g

06-2010

GC Instrument and Method Development

11-2004

AGILENT HPLC TRAINING

04-2004

Senior Team Leader – Quality Control

Dr. Reddy’s Laboratories Ltd.
03.1999 - 03.2026

B.Sc. - Botany, Zoology, Chemistry

Osmania University

Certification

AGILENT HPLC TRAINING

AUDIT & COMPLIANCE EXPERIENCE

  • Regulatory Audits: US FDA, WHO, ISO, PMDA, COFEPRIS, EDQM
  • Customer Audits: Cipla, Sunpharma, Merck (Organon)
  • Internal Quality Audits & Compliance Reviews
ANANTH KUMAR THASOJUPharmaceutical Quality Lead