Kavetha A/P Shanmugam
Johor
Summary
Accomplished IRCA-certified ISO 9001:2015 Lead Auditor with over 5 years in manufacturing, biotechnology, and accredited laboratories. Expertise in Quality Management Systems, GMP, HACCP, and ISO/IEC 17025 compliance. Led certification audits, reduced non-conformities, enhanced audit readiness, and fostered continuous improvement across cross-functional teams.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Head of Quality
Bioprout (M) Sdn. Bhd.
10.2025 - Current
- Lead plant-wide Quality Assurance and Food Safety systems covering GMP, HACCP, and regulatory compliance for manufacturing operations.
- Manage and continuously improve the Quality Management System (QMS) in line with GMP and HACCP requirements.
- Implemented upgraded QMS framework enhancing document control, traceability, and audit readiness.
- Lead HACCP team activities and food safety verification programs.
- Oversee Incoming Quality Control (IQC) for raw and packaging materials to ensure specification compliance.
- Establish and monitor In-Process Quality Control (IPQC) throughout production.
- Reviewed analytical and microbiological results to authorise Finished Product Release.
- Perform product quality trending and regulatory compliance monitoring.
- Led customer complaint investigations and implemented CAPA to address quality issues.
- Oversaw QC retention samples and maintained traceability program.
- Coordinate external laboratory testing for analytical and microbiological verification.
- Develop and maintain SOPs, Work Instructions, and quality documentation.
- Review and approve Batch Manufacturing Records (BMR) prior to product release.
- Key Achievements: Successfully passed external HACCP audit; Reduced quality non-conformities via strengthened process controls; Implemented new QMS system improving compliance visibility; Strengthened product release governance and audit readiness.
Quality Assurance Engineer
Eurofins Stats Asia Pacific Pte Ltd
02.2024 - 09.2025
- Supported product release decisions based on verified test data.
- Led CAPA activities from internal audits, reducing non-conformities by 15%.
- Maintained QMS compliant with ISO/IEC 17025 and ISO 9001 standards.
- Reviewed quality manual and improved document control processes for enhanced clarity.
- Coordinated quality programmes with external laboratories to ensure compliance and consistency.
- Implemented equipment calibration program and validation support.
- Maintained training records and competency matrix for audit readiness.
- Participated in Management Review and quality KPI monitoring.
- Impact: Improved audit performance and laboratory compliance.
Microbiologist
Eurofins Stats Asia Pacific Pte Ltd
01.2022 - 01.2024
- Managed microbiological testing for food, water, and medications, ensuring ISO 17025 compliance and quality assurance.
- Implemented streamlined microbiological testing processes, boosting efficiency by 20% without compromising accuracy.
- Led quality improvement initiatives, reducing non-conformities and earning recognition during external audits.
- Supervised laboratory operations, optimising staff scheduling, resource planning, and equipment calibration.
- Maintained meticulous ISO 17025 documentation, prepared NCRs, and ensured quick resolution of deviations.
- Conducted training for lab analysts and developed SOPs, improving compliance and operational efficiency.
- Supported internal and external audits, contributing to successful laboratory accreditation outcomes.
- Assisted as backup analyst for wet chemistry testing, providing support during team absences.
Executive, Quality Assurance
Sternmaid Asia Pacific Sdn Bhd
01.2018 - 12.2019
- Conducted chemical, microbial, and micronutrient analyses, ensuring compliance with specifications.
- Verified food safety and pest control systems, executing corrective actions to uphold regulatory compliance.
- Calibrated and ensured accuracy of testing instruments, improving measurement reliability.
- Implemented new sample preparation protocols for baby formula, enhancing accuracy and ensuring compliance with client standards.
- Developed coatings inspection checklist, streamlining inspection process and ensuring product quality.
Education
Master of Science - Biotechnology
Universiti Teknologi Malaysia (UTM)
Malaysia01-2022
Bachelor of Science (Hons) - Biology
The National University of Malaysia (UKM)
Malaysia01-2017
Skills
- Quality management system (QMS) implementation
- Regulatory compliance
- ISO standards
- Internal and external audits
- Lead auditor certification
- Good manufacturing practices
- HACCP principles
- CAPA processes
- Root cause analysis
- Risk assessment
- SOP development
- Quality control
Certification
- IRCA Certified ISO 9001:2015 Lead Auditor, EAS (Empowering Assurance Systems), 2026-03-29, 2031-03-29
- Food and Beverages Handling Certificate, KP Solutions, 2026-02-01
Projects
ELIMS Project, 2024-01-01, 2025-10-31, Facilitated QA/QC MicroLab sessions for 80+ users across management, laboratory, and client teams during 1-year ELIMS (Electronic Laboratory Information Management System) implementation. Led UAT coordination with IT team, developing test scenarios to validate system functionality and data integrity. Delivered system on time and within budget, achieving 70% reduction in data entry time, 89% improvement in data accuracy, and 78% reduction in manual errors. Enhanced GMP compliance by reducing manual documentation, ensuring ALCOA+ data integrity standards, and improving audit readiness. Successfully reduced inspection findings and strengthened overall compliance framework.
Websites, Portfolios and Profiles
https://www.linkedin.com/in/kavetha-shanmugam-233431130
Languages
Tamil
First Language
English
Advanced
C1
Malay
Advanced
C1
German
Beginner
A1
Timeline
Head of Quality
Bioprout (M) Sdn. Bhd.
10.2025 - Current
Quality Assurance Engineer
Eurofins Stats Asia Pacific Pte Ltd
02.2024 - 09.2025
Microbiologist
Eurofins Stats Asia Pacific Pte Ltd
01.2022 - 01.2024
Executive, Quality Assurance
Sternmaid Asia Pacific Sdn Bhd
01.2018 - 12.2019
Master of Science - Biotechnology
Universiti Teknologi Malaysia (UTM)
Bachelor of Science (Hons) - Biology
The National University of Malaysia (UKM)