Gayatri Ramsundar Iyer
Bedford,USA
Summary
Experienced professional with a strong background in food & beverages and medical foods, currently working in the medical food industry. Previously gained 6 years of experience in the flavor industry, 2 years in regulatory and compliance, and 1 year in healthcare. Proficient in various software, including analytical, database interface, and content workflow tools. Skilled in defect management, ensuring food quality standards, compliance monitoring, cross-functional collaboration, and customer complaint resolution.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Engineer
Ajinomoto Cambrooke
Ayer, USA
11.2023 - Current
- Acted as the go-to expert for ISO standards within the organization, ensuring adherence to cGMP and FDA regulations
- Provided strategic guidance on compliance matters, reducing non-conformances by 25% through robust system implementations
- Led the comprehensive documentation and successful deployment of ISO 9001, ISO 45001, and FSSC 22000 V5 programs
- Developed and delivered training programs to over 150 employees, achieving 100% compliance during the last audit cycle
- Established and maintained rigorous internal auditing schedules aligned with ISO standards, resulting in zero critical findings in consecutive external audits
- Coordinated with certifying bodies to streamline certification processes, reducing audit preparation time by 30%
- Conducted detailed analyses of quality systems data, identifying trends and areas for improvement
- Implemented data-driven initiatives that enhanced process efficiency, leading to a 15% reduction in product defects
- Directed thorough investigations into Non-Conformance Reports, Out of Specifications, customer complaints, and deviations
- Spearheaded root cause analysis and Corrective and Preventive Actions management, reducing recurring issues by 40%
- Provided critical input into resource allocation to optimize compliance efforts
- Supported the achievement of departmental goals by aligning compliance strategies with organizational objectives, contributing to a 20% increase in operational efficiency
- Worked closely with diverse teams, including R&D, production, and logistics, to resolve complex quality issues
- Set and managed deadlines, fostering a collaborative and positive work environment that enhanced project delivery timelines by 15%
- Proficiently implemented and maintained Quality Management Systems (QMS) across multiple standards such as FSSC 22000 V5, ISO 9001, and ISO 45001
- This expertise facilitated the organization’s successful transition to updated standards, ensuring continuous compliance and operational excellence
Assistant Manager QA & Regulatory
FoodChain ID
India
07.2021 - 04.2023
- Acted as the first responder to client tickets within 24 hours to confirm receipt of reported issues
- Determined the root cause of issues reported by customers
- Assigned tickets to appropriate staff members internally for processing or response
- Provided clients with detailed and comprehensive responses as needed
- Assisted in resolving data issues as required
- Conducted testing of development and production systems following step-by-step documentation
- Documented issues found during testing using the JIRA ticketing system
- Reported any system outages discovered during testing to the infrastructure team
- Provided feedback to the development team on system improvements related to user-friendliness
- Researched and corrected data inconsistencies to ensure data accuracy
- Reviewed assigned regulations to confirm the correctness of data values associated with country regulations
- Provided consultation and feedback on artwork labeling, recommended dietary allowance, and nutritional value calculations to ensure compliance with FSSAI norms for food product formulation and labeling
- Ensured compliance with regulations set by bodies such as FSSAI, HALAL, and Legal Metrology based on the product type
- Conducted lab testing to ensure product safety, including assessments for heavy metals, microbes, contaminants, and quality parameters as defined by FSSAI
Quality Assurance Executive
VKL Seasoning Pvt. Ltd (Flavors)
India
06.2015 - 07.2021
- Proficient in handling and operating a wide range of instruments and equipment used for quality control and analysis in the food industry
- Skilled in calibrating and setting up instruments to ensure precise measurements and reliable results
- Experienced in conducting tests and analyses using instruments such as pH meters, specific gravity meters, moisture analyzers, flash point testers, gas chromatography, lab-scale distillation, sensory evaluation equipment, refractometers, and bulk density equipment
- Adhered to standard operating procedures and followed Good Laboratory Practices (GLP) to maintain data integrity and traceability
- Knowledgeable in troubleshooting instrument issues and performing routine maintenance to ensure optimal performance and reduce downtime
- Accurately recorded and documented instrument readings, test results, and maintenance activities
- Ensured cleanliness and proper storage of instruments to prevent cross-contamination and maintain longevity
- Familiar with industry regulations and standards governing instrument calibration, validation, and quality control practices
- Demonstrated strong attention to detail and a meticulous approach to ensure accuracy and reliability in testing and analysis
- Possessed excellent organizational and time management skills to prioritize instrument handling tasks and meet deadlines
- Demonstrated expertise in performing quality control functions to ensure the safety, quality, and compliance of food products
- Conducted inspections and testing of raw materials, ingredients, and finished products to verify adherence to quality standards and regulatory requirements
- Proficient in various testing methods, including sensory evaluation, chemical analysis, microbiological testing, and physical measurements, to assess product quality and attributes
- Developed and implemented quality control procedures, protocols, and documentation systems for consistent product quality and regulatory compliance
- Conducted audits and inspections to monitor critical control points and identify potential risks in the production process
- Collaborated with cross-functional teams to resolve quality-related issues, implementing corrective actions and preventive measures
- Maintained accurate records of quality control activities, including test results, inspection reports, corrective actions, and compliance documentation
- Stayed updated with industry regulations, food safety guidelines, and labeling requirements to ensure compliance
- Active member and panelist of the flavor sensory evaluation team, responsible for assessing and analyzing the sensory attributes of food products
- Proficient in sensory evaluation techniques to evaluate flavor profiles, taste, aroma, texture, and overall sensory experience of food samples
- Participated in sensory panels and conducted descriptive sensory analysis to provide insights on product quality and consumer acceptance
- Trained in sensory evaluation methods, such as discrimination testing, descriptive analysis, hedonic scales, and attribute intensity evaluations
- Applied statistical analysis and data interpretation to draw conclusions from sensory test results
- Collaborated with teams including product development, quality control, and marketing to provide sensory feedback for product optimization
- Contributed to flavor profiling and development projects, working with flavorists and product developers to create and refine flavors
- Maintained sensory evaluation records, documentation, and protocols to ensure compliance with industry regulations
- Demonstrated attention to detail and consistency in sensory evaluations for reliable and accurate results
- Possessed excellent sensory perception and discrimination skills to detect subtle differences in flavor, aroma, and texture
- Communicated sensory feedback effectively in a collaborative team environment
Patient Care Executive
M/s. Health Impetus Pvt. Ltd
India
05.2014 - 06.2015
- Enrolled patients for therapy tests and ensured their successful participation in the treatment program
- Monitored patient progress to ensure completion of the entire treatment course for chronic diseases
- Maintained the Management Information System (MIS) for tracking and reconciling enrolled and non-enrolled patients
- Reported adverse events, prepared doctor counseling reports, updated lab records, and obtained doctor and patient consent as required
- Managed and updated forms, maintained strong patient relationships, and facilitated the distribution of complimentary items to patients
- Successfully implemented FSSC 22000 Certification in the facility
- Installed and implemented Gas Chromatography (GC) Instrument in the plant for advanced quality analysis
- Led Cost Improvement Projects to enhance operational efficiency and reduce expenses
- Implemented 5S Methodology in the facility to improve workplace organization and productivity
- Executed multiple projects with Firmenich, ensuring high standards and successful outcomes
- Established Regulatory Document Control systems to streamline compliance and documentation processes
Education
B.Sc. - Biotechnology, Chemistry & Microbiology
Ideal College, Osmania University
Hyderabad01.2010
Skills
Quality Control & Assurance:
Expertise in GMP, GHP, GLP, FSSC 22000, ISO 9001, and ISO 45001 compliance; sensory evaluation; root cause analysis; and CAPA implementation
Regulatory Compliance:
Proficient in FSSAI, HALAL, Legal Metrology, and FDA regulatory standards
Technical Skills:
Skilled in instrument handling (GC, HPLC, refractometers), sensory evaluation techniques, and statistical process control
Software Proficiency:
Experienced with Zendesk, CRAQEN, Atlassian JIRA, Microsoft Access, SAP QM, and ERP systems
Certification
- FSPCA Preventive Controls for Human Foods: Preventive Controls Qualified Individual (PCQI), Penn State College of Agricultural Sciences, Pennsylvania
- FSSC 22000 V5 Internal Auditor, Intertek (HACCP & GMP)
- ISO 45001 Internal Auditor, NSF
- Quality Assessment of Essential Oils/Aroma Chemicals Using Modern Instrumental Techniques, FFDC
- FSMS Internal Auditor, Bureau Veritas
- Certified Quality Auditor
- Food Safety Training and Certification Program (FoSTaC)
- Leadership Training, External by Organization
- Chromatographic Techniques (GC, HPLC, UHPLC) & Their Analytical Approaches in Food Analysis, CFTRI
Accomplishments
- Successfully implemented FSSC 22000 Certification in the facility.
- Installed and implemented Gas Chromatography (GC) Instrument in the plant for advanced quality analysis.
- Led Cost Improvement Projects to enhance operational efficiency and reduce expenses.
- Implemented 5S Methodology in the facility to improve workplace organization and productivity.
Timeline
Quality Engineer
Ajinomoto Cambrooke
11.2023 - Current
Assistant Manager QA & Regulatory
FoodChain ID
07.2021 - 04.2023
Quality Assurance Executive
VKL Seasoning Pvt. Ltd (Flavors)
06.2015 - 07.2021
Patient Care Executive
M/s. Health Impetus Pvt. Ltd
05.2014 - 06.2015
B.Sc. - Biotechnology, Chemistry & Microbiology
Ideal College, Osmania University
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