Mamatha K G
Bengaluru
Summary
Dynamic Quality Assistant Manager with extensive experience at VSIX Analytical Labs, excelling in implementing QMS and ensuring compliance with NABL standards. Proven expertise in method validation and audit management, complemented by strong leadership and training skills. Committed to driving quality improvements and fostering a culture of excellence in laboratory operations.
Overview
18
18
years of professional experience
3
3
Languages
Work History
Quality Assistant Manager - Food, Water & Drug Testing
VSIX Analytical Labs Pvt. Ltd.
02.2024 - Current
- Implementing and monitoring the Quality Management System (QMS) as per NABL guidelines.
- Actively involved in LIMS (Laboratory Information Management System) implementation, including:
- Sample registration and tracking
- Data entry and result verification
- Report generation and record control
- Handling and coordinating Drug Audits and Customer Audits, ensuring compliance with regulatory and client-specific requirements.
- Ensuring laboratory activities meet FSSAI regulations and testing requirements for food and water samples.
- Supporting internal audits, NABL assessments, and management review meetings.
- Preparing and maintaining SOPs, quality manuals, validation protocols, calibration records, and audit documentation.
- Monitoring method validation, equipment calibration, traceability, and corrective actions.
- Ensuring proper handling of non-conformities, customer complaints, and CAPA.
- Working in a NABL-compliant laboratory for Food, Water, and Drug testing in accordance with ISO/IEC 17025:2017 standards.
Senior Microbiologist
BIO-GEN EXTRACTABLE PVT LTD
01.2012 - 01.2023
- New Microbiology laboratory setup, Equipment, Instrument qualifications, Area qualification and water system qualification.
- Responsible for review of Microbiology laboratory activities related to sampling, testing, reporting, and release as per the schedules.
- Involved in preparation of standard operating procedures.
- Involved in Preparation of Specifications & Method of analysis as per USP/BP/IP and in-house regulations.
- Responsible for preparation of Qualification documents like IQ, OQ & PQ for analytical Equipment and Instruments.
- Operation and calibration of instruments and equipment's.
- Review of lab records and quality related documents.
- Trained new analysts on a wide variety of methods and instruments.
- Involved in QA activities like raising the change control for Specifications, method of analysis and standard operating procedures.
- Involved in Internal audit programs.
- Coordination of external calibration schedule with external agencies.
- Preparation/Review of SOPs, STPs / Work sheets, Specifications, Validation protocols and COAs.
- Handling of Change controls, Incidents, Deviations and CAPA through TRACK WISE.
- Monitoring the personnel training program.
Microbiologist
Bureau Veritas Customer Product India PVT LTD
10.2010 - 05.2012
- Authorized signatory for microbiological testing of Food and water samples.
- Microbiological analysis of all types of Food, Dairy, Spices, Beverages & Water samples as per IS, ISO and BAM.
- Preparation of SOPs and maintenances of all relevant documentation and records as per norms.
- Internal calibration verification of instruments and Equipment's.
- Handling and Maintenance of reference cultures.
- Packaged drinking water testing as per BIS - IS 14543.
Microbiologist
Bangalore Test House
01.2008 - 01.2010
- Responsible for testing of Food, Dairy, Spices, Beverages, Environmental Samples & Water samples as per IS, IP and USP.
- Responsible for various phase of quality aspects including data reviews and laboratory audits based on ISO 17025 guidelines for NABL accreditations & BTS.
- Microbial Limit Test, Assay of Vitamin B12 & Sterility - Blood Samples as per IP.
- Packaged Drinking Water testing as per BIS - IS 14543.
- Experience on testing of preservative effectiveness.
Education
M.Sc. - Microbiology
Kuvempu University
01.2008
B.Sc. - Chemistry, Zoology, Botany
Kuvempu University
01.2006
Skills
Team leadership
Training and onboarding
Audit and compliance
Laboratory management
Microbiology analysis
Method validation
Equipment qualification
Industry expertise
Audit experience (USFDA, ISO)
Internal auditing
Quality management system (QMS)
Qualification and validation
Timeline
Quality Assistant Manager - Food, Water & Drug Testing
VSIX Analytical Labs Pvt. Ltd.
02.2024 - Current
Senior Microbiologist
BIO-GEN EXTRACTABLE PVT LTD
01.2012 - 01.2023
Microbiologist
Bureau Veritas Customer Product India PVT LTD
10.2010 - 05.2012
Microbiologist
Bangalore Test House
01.2008 - 01.2010
B.Sc. - Chemistry, Zoology, Botany
Kuvempu University
M.Sc. - Microbiology
Kuvempu University