Summary
Overview
Work History
Education
Skills
Accomplishments
Employment Position
Personal Information
Timeline
Generic

Kani Mozhi Ganesan

Coimbatore

Summary

With a proven track record at Biosystems Diagnostics, I've excelled in enhancing quality compliance and operational efficiency, leveraging skills in ISO 13485 and risk management. Recognized for outstanding contributions with three consecutive Best Employee awards, I blend technical prowess with exceptional team leadership to drive continuous improvement and regulatory adherence.

Overview

5
5
years of professional experience

Work History

QA/QC In Charge - Hybrid Based

Biosystems Diagnostics
Kanchipuram
01.2019 - 06.2022
  • Ensure compliance with the ISO 13485:2016 standard and other regulatory requirements to maintain the QC testing documentation and QMS.
  • Document Control: Preparation of Standard Operating Procedures and Work Instructions.
  • Lead internal audits, ensure that all nonconformities are addressed, and then CAPA (Corrective and Preventive Actions) is taken to improve the QMS.
  • Software validation and report generation are performed according to the regulatory requirements for semi-auto analyzers and Auto analyzers.
  • Supporting team members in risk analysis and preparing a risk management report according to ISO 14971, related to the manufacturing of instruments.
  • Regularly review the obtained final control test results, their instrument release certificate, and ensure compliance.
  • Preparation of technical documentation as per IVDR 2017/746.
  • Process validation documentation related to QC, instruments, and biochemistry reagents.
  • Review of testing results of components performed in the incoming inspection.
  • Review of calibration-related activities and record review as per the requirement.
  • Review of the Device History Record after the completion of assembly and final control.
  • Semi-Auto Analyzer - BTS complaint review, compilation, and follow-up on Product Complaint Record.
  • Review the internal study reports, and record the issues in the document as per the requirements, in accordance with regulatory requirements.

QA Executive

Biosystems Diagnostics
Kanchipuram
01.2018 - 01.2019
  • Archival, documentation of Master, distribution of Controlled copies of Effective SOP's as per the user department requirement.
  • Supporting team member in Investigation of non-conformance batches and its documentation.
  • Preparation of Stability Schedule, Reports and Submission to Department Head.
  • Supporting team member in preparing schedule and receipt of instruments due for Calibration to External Calibration Agency.
  • Team member as an auditee in ISO, cGMP and other client Audits and in helping closure of audit observations.
  • Attending several internal and External Training programmes related to ISO 13485.
  • Conduct Revised SOP Training and QMS training as per the requirement.
  • Manage all quality related activities
  • Review process control plan, drive quality issues to root cause, corrective actions and improvement, track quality performance.
  • Coordinate customer visits and audits
  • Assist in developing quality goals and improvement plans.
  • Documentation and procedure compliance related to QMS System
  • Establish, Preparation of quality procedures an conduct training for the User department.
  • Possess skills in Process yield monitoring, Quality Improvement, Failure Analysis, FMEA.
  • Involve in all QA related activities and closure of all QMS related documents.

QC/QA Trainee

Biosystems Diagnostics
Kanchipuram
01.2017 - 01.2018
  • Analysis of In process-Bulk, Semi-finished product Filling and Finished product Samples.
  • Sampling of Raw-material, Packing Materials, analysis, release and documentation of the same.
  • Sampling of Purified Water samples, Effluent Water samples on schedule basis to external Laboratory.
  • Calibration and Control procedures of Laboratory Instruments - pH meter, Conductivity meter, Photometer and Auto analyser etc.
  • Status labelling and identification of Finished, Stability and Retained samples and maintenance of associated documents.
  • Preparation of QC/QA related SOP's, Formats and other GMP records as per cGMP, ISO 13485 guidelines.
  • Active participation in analysis of NC batches, under study batches etc.
  • Analysis and documentation of External Laboratory Assessment Programmes of Bio systems BS.

Education

Msc. Applied Microbiology -

Madras Christian College affiliated to Madras University
Kanchipuram
01.2016

Bsc. Microbiology -

PSG College of Arts and Science affiliated to Bharathiar University
Coimbatore
01.2014

Alvernia Matric; Hig; Sec; School -

Coimbatore
01.2011

Skills

  • Certified Internal Quality Auditor as per ISO 13485, Trained at BSI
  • Handled Internal QMS Training as per ISO 13485
  • External Auditee - Ensure the compliance as per ISO 13485
  • Attended Risk Management Training as per ISO 14971
  • Supporting Team member in Risk analysis and GAP Analysis
  • Technical document preparation as per MDR 2017 For Semi auto analyzer/ Device Master file preparation / Validation/CE Marking
  • Attended eCTD document Training at Biosystems
  • Certified Regulatory Affairs Professional Training at Biosystems
  • Regulatory Compliance-QMS Documentation Control - Document Preparation & Review related to QC and QA
  • Ability to Diagnose, analyze the issues in the Production and QC In-Line at Instruments and Troubleshooting guide prepared for preventing or resolving the issues
  • Practical experience in Handling of Semi Auto & Auto analyzers, HA Analyzer / Internal Batch study for NC , Stability Study test & Report generation as per the requirement
  • Customer Compliant Handling as per the Requirement
  • Six Sigma Methodologies/Process Analysis/Trend Analysis and report generation/CAPA
  • Semi auto analyzer Software testing, Report Generation and Data Analysis
  • Awarded as Best Employee of 2019,2020 & 2021
  • Dubai trip 2020 - Conference held in Dubai , as project compliment
  • Presentations and General SOP and QMS Training to the Departments and Cross- Functional departments according to the Regulatory requirements
  • Personnel Training

Accomplishments

Dubai Trip - Conference 2020 - As a compliment - working under Instrument manufacturing Project.

Awarded as Best Employee of 2019,2020 & 2021.

Certified Internal Quality Auditor.

Certified Regulatory Affairs Professional.

Employment Position

QA/QC

Personal Information

  • Date of Birth: 03/20/1993
  • Nationality: Indian

Timeline

QA/QC In Charge - Hybrid Based

Biosystems Diagnostics
01.2019 - 06.2022

QA Executive

Biosystems Diagnostics
01.2018 - 01.2019

QC/QA Trainee

Biosystems Diagnostics
01.2017 - 01.2018

Msc. Applied Microbiology -

Madras Christian College affiliated to Madras University

Bsc. Microbiology -

PSG College of Arts and Science affiliated to Bharathiar University

Alvernia Matric; Hig; Sec; School -

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Kani Mozhi Ganesan