Summary
Overview
Work History
Education
Skills
Professional Overview
Certification
Timeline
Generic

Sathya Moorthy

GMP and ISO Quality Management Systems Professional
Bangalore

Summary

Experienced GMP and Quality Assurance professional with a proven track record in planning, directing, and managing outsourced pharmaceutical services. Specializes in ensuring GMP and ISO compliance, method validation, process optimization, and laboratory accreditation. Certified NABL Assessor with extensive expertise in conducting audits, assessments, and driving quality improvements in high-pressure environments.

Overview

20
20
years of professional experience
4
4
Certifications
3
3
Languages

Work History

Deputy General Manager - QA

Shiva Analyticals (India) Private Limited
11.2014 - Current
  • Company Overview: Part of the Cotecna Group
  • Led the implementation of global compliance standards on cGMP as per USFDA, MHRA, EU-GMP etc., along with ISO 17025:2017, ISO 45001:2018 as well.
  • Managed method validation and transfers, performed root cause analysis, and developed quality systems, procedures, and policies to meet regulatory and customer quality requirements while reducing product quality deviations.
  • Led the pharmaceutical laboratory through successful USFDA inspections and numerous NABL, ISO and CDSCO inspections with minimal non-conformances and reduced audit findings by 30% through a proactive audit approach.
  • Conducted audits as a certified NABL Assessor to ensure laboratory accreditation and address non-conformances.

Associate Scientist-II

Vanta Bioscience - Kemin Industries South Asia Ltd.
05.2013 - 10.2014
  • Led the establishment and regulatory approval of an OECD-GLP-compliant phys-chem studies lab as study director, overseeing study protocol development, analytical support for toxicological studies, and method validation using advanced techniques (GC, HPLC, LC-MS/MS).

Senior Research Scientist-II

Eurofins-Advinus Limited
12.2005 - 04.2013
  • Study Director for OECD-GLP studies involving Phys-chem and residue studies using LC-MS, GC-MS etc.
  • Led OECD-GLP pesticide residue studies using advanced analytical techniques (SPE, LLE, HPLC, GC-MS, LC-MS), ensuring compliance, data accuracy, and successful audits by Indian GLP authorities.

Scientist - Grade II

International Institute of Bio-technology and Toxicology (IIBAT)
11.2004 - 10.2005
  • Functioned as Study Director in managing OECD-GLP pesticide residue studies including method validations and conducted field trials, contributing to successful regulatory approvals and a 25% increase in analysis efficiency through the implementation of new HPLC methods.

Education

Bachelor's degree - Chemistry

Bharathiar University
Coimbatore, India

Master's degree - Applied Chemistry

Coimbatore Institute of Technology
Coimbatore, India
01.2003 -

Skills

Knowledge of cGMP regulations

Professional Overview

Experienced QA professional with 20+ years in the pharmaceutical industry, specializing in GMP & ISO compliance, method validation, process optimization, and laboratory accreditation. Certified NABL Assessor with expertise in audits, assessments, and driving quality improvements in high-pressure environments.

Certification

Certified NABL Assessor as per ISO 17025:2017

Timeline

Deputy General Manager - QA

Shiva Analyticals (India) Private Limited
11.2014 - Current

Associate Scientist-II

Vanta Bioscience - Kemin Industries South Asia Ltd.
05.2013 - 10.2014

Senior Research Scientist-II

Eurofins-Advinus Limited
12.2005 - 04.2013

Scientist - Grade II

International Institute of Bio-technology and Toxicology (IIBAT)
11.2004 - 10.2005

Master's degree - Applied Chemistry

Coimbatore Institute of Technology
01.2003 -

Bachelor's degree - Chemistry

Bharathiar University
Sathya MoorthyGMP and ISO Quality Management Systems Professional