Summary
Overview
Work History
Education
Skills
Certification
Interests
Timeline
SeniorSoftwareEngineer

Indhu Chidambaram

Quality Management Professional
Bangalore,Karnataka

Summary

· Strategic Quality Assurance Executive bringing Four years of experience establishing requirements to meet quality assurance objectives in Food industry. Proficient in LIMS,DMS & QAMS. Analytical and resourceful professional recognized for improving customer satisfaction by observing and addressing trends and patterns of customer complaints.

· Quality Management professional with successful career delivering efficiency and standardization, and maintaining all ISO and IS standard,and Compliance with ISI/IEC 17025 Experience in reviewing and interpreting regulatory and programmatic guidance, implementation of corporate compliance, risk management and corrective action.

Overview

1
1
Certification
5
5
years of post-secondary education
4
4
years of professional experience

Work History

Quality Assurance Executive

ALS Testing Service India Pvt Ltd
Bangalore, Karnataka
08.2020 - 10.2020
  • Ensuring the laboratory QMS operates according to compliance objectives of regulators such as NABL, FDA,US FDA, TGA, BIS etc.
  • Production of quality documents, records and metrics.
  • Communication and training of quality related documentation and tools.
  • Issuance and archival of quality documents.
  • Conducting audits as required.
  • Preparation for and participation in external audits.
  • Responsibility to ensure compliance with calibration requirements of all equipment including documenting requirements, and calibration activities.
  • Responsibility for ensuring technical compliance of ALS policies, methods, procedures etc. with accreditation and regulatory requirements.
  • Review and approval of Test Reports, Method Development, Analytical Method Validation and Verification reports. Review and release ROA and COA.
  • Review and approval of CAPA, Deviations, OOS/OOT and Change Control in QAMS.
  • Administrator for QAMS and DMS.
  • Working with business and laboratory management on issues related to quality and assist with resolution of Quality Events as needed.
  • Participate in management reviews as required.
  • Ensuring QMS documentation is meeting regulatory and ALS India procedures in DMS.
  • Conduct the Quality assurance check programs.
  • Identification for the Scope of improvement.

Quality Assurance Executive

Eurofina Analytical Service India Pvt, Ltd
Bangalore, Karnataka
04.2019 - 07.2020
  • Compliance with Quality Documents as per ISO/IEC 17025-2017 requirements.
  • Familiarity with the operation of the Eurofins - Quality System.
  • Ensure documentation in the Quality System is accurate, compliant and follow GxP.
  • Participate in audits by external accreditation and certification bodies in NABL, FDA, US FDA, BIS, APEDA, FSSAI & TGA etc.
  • Ensure equipment calibration and maintenance activities align with accreditation and supplier requirements.
  • Ensure equipment related documentation in the Quality System is accurate and compliant.
  • Conduct internal audits as defined in the internal audit schedule
  • Effectiveness of the CAPA
  • Analytical data review and validation.
  • Uploading Reports in regulatory bodies like APEDA, IOPEPC,FSSAI.
  • Conduct IQC, ILC and PT.
  • Assisted with the development, maintenance of Quality metrics
  • Implemented customer complaint system and root-cause problem solving, decreasing customer complaints.

Regulatory Affairs and LIMS Super User

SGS India Pvt, Ltd.
Chennai, Tamilnadu
02.2016 - 03.2019
  • Identified issues, analyzed information and provided solutions to Customers.
  • Trained SUPERUSER for LIMS (Laboratory Information Management system) in the Food and Agriculture section which includes scheme creation, Procedure Creation and Verification.
  • Gathered, evaluated, organized, managed and collated information in varying formats.
  • Assisted with regulatory product compliance initiatives such as FSSAI,APEDA,BIS,SFDA,CODEX,USFDA,EU regulations for Food and Feed, Crop exports etc...
  • Troubleshooting SLIMS related issues concerning to test reports.
  • Adding compliance limits in test reports and compliance remarks for product matrix as per specified regulatory bodies.
  • Confirmation of Lab capability for standard / In- house SOP/ Customer Method.
  • Daily checks - Review and verification of test methods, Specifications, Regulatory information in test reports.
  • To check test reports compliance with specified standards/Regulation/Guidance.
  • Co-ordination and Data compilation for test method validation projects and Verification.
  • Co-ordination with Laboratory and Quality Department to prepare SOP's.
  • Updating data and Preparing lab capability matrix as per Regulatory bodies.
  • Daily checks on All regulatory bodies information/notifications and updating Lab in charges.
  • Analyze and prepare Business statistical data for Weekly/ Monthly & Yearly.

Education

Master of Science - Food Technology And Management

M.O.P Vaishnava College For Womes
Chennai
06.2013 - 05.2015

Bachelor of Science - Microbiolgy

Ethiraj College For Womes
Chennai
06.2010 - 05.2013

Skills

    Quality processes

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Certification

FOSTAC -Manufacturing (Level 2) - Food safety Supervisor

Interests

Love to do Morden Art Contemporary & Post modern

Learning portraits

Timeline

Quality Assurance Executive

ALS Testing Service India Pvt Ltd
08.2020 - 10.2020

FOSTAC -Manufacturing (Level 2) - Food safety Supervisor

08-2019

Quality Assurance Executive

Eurofina Analytical Service India Pvt, Ltd
04.2019 - 07.2020

Regulatory Affairs and LIMS Super User

SGS India Pvt, Ltd.
02.2016 - 03.2019

Master of Science - Food Technology And Management

M.O.P Vaishnava College For Womes
06.2013 - 05.2015

Bachelor of Science - Microbiolgy

Ethiraj College For Womes
06.2010 - 05.2013
Indhu ChidambaramQuality Management Professional