YASH GANDHI

• Operated and monitored process equipment, including autoclaves, filling machines, mixers, vacuum pumps,and peristaltic pumps.
• Maintained detailed documentation records for autoclave operations, including Bowie-Dick tests, product cycle logs, and leak test reports, ensuring ISO 13485 compliance.
• Conducted syringe inspections to identify defects, including overfill, underfill, air bubbles, and gel residues, ensuring adherence to Inspection SOP.
• Update Data in paperless work SOP post-process completion and ensured accurate labeling in manufacturing work SOPs in compliance with ISO 13485.
• Assisted in the validation of autoclave and ensured documentation with compliance of ISO 17665.
• Work in a fast-paced environment with high precision in inspection. ensuring that all batches met QA regulations.
• Proficient in using mechanical inspection tools (vernier calipers, micrometers) and calibrating equipment including pumps, temperature gauges, weighing scales, conductivity meters, and pH meters, with expertise in sanitizing equipment to maintain compliance with quality standards

.

• Adhered to best manufacturing practices for the operation of production plastic bottle machinery, ensuring consistent product quality.
• Adjusted machine feed and speed to correct machine malfunctions.
• Minimized machine downtime by promptly identifying and escalating technical issues.
• Excelled in a fast-paced environment, maintaining high levels of accuracy.

• Prepared Quality Assurance Plans (QAPs) and User Requirement Specifications (URS) for pressure vessels, heat exchangers, and pharmaceutical equipment After PO.
• Coordinated with the Design department to ensure design verification and validation, including dimensional checks, FEA analysis, process flow via pipelines, and material selection (pumps, valves, and instruments).
• Proficient in AutoCAD for 2D drafting, layout design, and technical drawings and Extensive experience with SolidWorks, including 3D modeling, part and assembly design.
• Maintained document records in accordance with ISO 9001:2015 standards, ensuring the proper control version, approval, and distribution of documents to meet audit requirements.
• Reviewed, updated, and audited procedures, work instructions, and specifications to ensure ongoing compliance and ensured proper traceability and accessibility of records to support continuous improvement.
• Facilitated root cause analysis for identified issues, managed non-conformance reports, and implemented corrective actions, effectively preventing recurrence of quality assurance.
• Implemented ISO 9001:2015 standards, providing technical training to employees on documentation control, QMS processes, and continuous improvement methodologies.
• Developed IQ, OQ, and PQ protocols for filtration systems, executing on-site validation and qualification activities to verify system performance and compliance with regulatory and technical standards.
• Responsible for communicate with customer regarding quality issues, addressing concerns related to USR (User Specification Requirements), ensuring compliance, and providing solutions to achieve customer satisfaction and maintain strong relationships.
• Maximized profit margins while maintaining quality standards through critical evaluation of vendor quotes for materials and services.
• Review & inspection of MTC Using ASME sec-II Vol.1 & 2, Inspection Flanges (ASME B 16.5 &
  16.47),Pipes & Fittings as per (ANSI Pipe Chart, ASME B 16.9 & B16.11),Metallic & Non-Metallic
  Gaskets as per (ASME B 16.20 & 16.21).
• Strong experience in ASME Sec. VIII and ASME Sec. IX, specializing in the development and qualification of WPS, PQR, and WPQ for TIG welding on equipment as a certified welding inspector.
• Conducted site visits to gather information and data on project locations, infrastructures and conditions.
• Negotiated contracts with suppliers and vendors, securing best pricing for materials and instruments.

• Inspection of Mold dimension of Aluminum casting
• Data record of Heat treatment and quenching.
• Inspection And Data Record of the Tensile Testing and Chemical Testing
• Data record of Coordinate measuring machine (CMM)
• Witness of Hydro testing and Helium leak testing.
• Drafted and revised Die 3D model to meet client specifications.
• Utilized Solidworks 3D to add detail dimensions of core in Mold cavity.
• created plant layout in autocad 2D.