Love to do Morden Art Contemporary & Post modern.
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
2020.08 - 2020.10
- 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
2019.04 - 2020.07
- 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
2016.02 - 2019.03
- 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 2013.06 - 2015.05
Bachelor of Science - Microbiolgy
Ethiraj College For Womes
Chennai 2010.06 - 2013.05
Skills
Quality processes
Certification
FOSTAC -Manufacturing (Level 2) - Food safety Supervisor
Interests
Learning portraits
Timeline
Quality Assurance Executive
ALS Testing Service India Pvt Ltd
2020.08 - 2020.10
FOSTAC -Manufacturing (Level 2) - Food safety Supervisor
2019-08
Quality Assurance Executive
Eurofina Analytical Service India Pvt, Ltd
2019.04 - 2020.07
Regulatory Affairs and LIMS Super User
SGS India Pvt, Ltd.
2016.02 - 2019.03
Master of Science - Food Technology And Management
M.O.P Vaishnava College For Womes
2013.06 - 2015.05
Bachelor of Science - Microbiolgy
Ethiraj College For Womes
2010.06 - 2013.05
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