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, IndiaMaster's degree - Applied Chemistry
Coimbatore Institute of Technology
Coimbatore, India 01.2003 -
Skills
Knowledge of cGMP regulations
Analytical Method Development, Validations and Verifications
Extractables & Leachables
Data Integrity and Audit Trail
Root Cause Analysis & CAPA
Regulatory Compliance (Schedule - M, USFDA, MHRA, WHO, ISO)
Audits and Inspections
Computer System Validations (CSV) as per 21 CFR Part 11, EU Annex 11, GAMP 5
Interdisciplinary team leadership
Employee training
Collaborative team development
Team leadership
Effective team leadership
Problem-solving expertise
Proven leadership skills
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