YASH GANDHI
North York,Ontario
Summary
Accomplished QMS Head at MICROFILT INDIA PVT. LTD, adept in ISO 9001:2015 and ASME standards, significantly enhanced product quality and efficiency through strategic implementation of GMP guidelines and Lean Manufacturing techniques. Expert in root cause analysis, fostering strong client relationships. Demonstrates exceptional leadership and problem-solving skills.
Overview
7
7
years of professional experience
1
1
Certification
Work History
QMS HEAD
MICROFILT INDIA PVT.LTD
04.2019 - 06.2024
- Played an instrumental role in achieving ISO 9001:2015 certification for the organization through documents preparation and audit activities.
- Streamlined document processing for increased efficiency by developing and enforcing standardized procedures.
- Ensured timely completion of audit tasks for CE certification job for Filtrox.
- Developed detailed technical documents: QAP, User requirement specification,SOP, Installation qualification, operation qualification, CAPA, Non -conforming records, checklists, Design qualification protocols.
- Monitored pre and post-production operations for compliance with Good Manufacturing Practice (GMP) guidelines.
- Conducted root cause analyses for identified issues, leading to targeted corrective actions that improved overall process effectiveness.
- Participated in change management initiatives related to documentation updates, facilitating smooth transitions between old and new procedures.
- Hands on experience with SIMATIC PLC, HMI, and SCADA systems.
- prepared testing procedure for instruments like pressure, temperature, flow transmitter quality assurance purposes before installation or repair work commenced
- Analyzed customer feedback data, using insights gained to drive improvements in future designs.
- Implemented Lean Manufacturing techniques to reduce waste and improve overall product quality levels.
- Verification detailed 3D models and drawings, ensuring accurate communication of design intent to fabrication teams.
- Developed strong relationships with clients by maintaining open lines of communication throughout the audit process.
- expertise in handling TPI and AUDIT such as, TUV nord, TUV SUD, LLOYD, IRCLASS and FDA third party.
QC ENGINEER
VNP ELETRICALS PVT.LTD
01.2018 - 03.2019
- Prepared, documented and executed detailed test plans, test cases and defect reports.
- Maintained electronic and hard copies of heat treatment, quenching and final machining inspection record.
- Created product specification notebooks, reducing defects on parts by 20%.
- Interfaced with suppliers, inspectors and clients to resolve outstanding non-conformance issues prior to shipment.
- Performed and coordinate dimensional, visual inspections and determined quality assurance testing models of raw materials and finished products.
Junior Quality Engineer
Superkino Equipments Pvt.ltd
07.2017 - 12.2017
- Enhanced product quality by conducting thorough inspections and implementing corrective actions.
- Streamlined workflow efficiency by identifying areas for improvement in existing procedures.
- Machining final dimensional inspection.
- Maintain CMM data record.
Education
Bachelor of Science - Mechanical Engineering
Laxmi Institute of Technology
India06.2017
Skills
- ISO 9001:2015 Quality management system
- ASME SEC VIII , IX ,IV, V
- GMP, cGMP, GD and T
- Technical and Quality assurance Documentation
- Computer Skills: master excel, microsoft office, ERP quality module
- Autocad 2D, Solidworks 3D, NX CAD
- CNC machining and programming
Accomplishments
- Successfully completed the documentation and Third Party Inspection (TPI) process for obtaining CE marking certification for Filtrox.
- Successfully completed the documentation and Third Party Inspection (TPI) process for obtaining for Thermo-fisher equipment.
- Successfully Implemented the ISO 9001; 2015
- Successfully completed the installation and commissioning of COVID-19 Pre vaccine Depth Filtration System at ZYDUS Pharmaceuticals.
Languages
English
Full Professional
Certification
- CSWIP 3.1 WELDING INSPECTOR
- 7 QUALITY TOOLS
- PPAP
- ROOT CAUSE ANALYSIS AND 8D CORRECTIVE ACTIONS PROCESS
- ISO 9001 : 2015 QUALITY MANAGEMENT SYSTEM
Timeline
QMS HEAD
MICROFILT INDIA PVT.LTD
04.2019 - 06.2024
QC ENGINEER
VNP ELETRICALS PVT.LTD
01.2018 - 03.2019
Junior Quality Engineer
Superkino Equipments Pvt.ltd
07.2017 - 12.2017
Bachelor of Science - Mechanical Engineering
Laxmi Institute of Technology
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