Akshat Mehta

Robotics-Based Manufacturing Operations: Operated automated robotic dipping systems used in the investment casting process for knee and hip prosthetic components, ensuring compliance with validated manufacturing recipes. Slurry Dipping & Mold Preparation: Performed multi-stage slurry dipping and sand coating of wax molds using chemical-based formulations tailored to specific implant sizes and product categories. Process Parameter Control: Monitored and controlled critical slurry parameters including viscosity, pH, and temperature; performed controlled chemical and distilled water adjustments to maintain required operating ranges. Controlled Environment Management: Maintained room temperature and slurry tank conditions to support mold integrity, drying cycles, and downstream metal pouring operations. Equipment Monitoring & Troubleshooting: Supported setup, monitoring, and basic troubleshooting of robotic equipment, identifying process deviations and escalating issues to engineering or maintenance teams. GMP Documentation & Compliance: Documented process data, inspections, and adjustments in accordance with GMP, SOPs, and internal manufacturing documentation requirements. Cross-Functional Manufacturing Support: Coordinated with casting, inspection, and finishing departments to ensure smooth production flow and consistent product quality.

Developed and implemented SOPs for quality ingredient testing, ensuring regulatory compliance and accuracy in manufacturing processes. Maintained batch records, conducted quality control checks on raw materials and finished goods, and supported R&D activities to drive new product development. Led CAPA initiatives, investigated non-conformances, and collaborated with cross-functional teams to uphold quality standards. Managed raw material sourcing and inventory control to support uninterrupted production. Operated tablet press machinery, performed torque and blister leak tests, and trained staff on quality assurance procedures and safety protocols. Assisted in internal audits and stayed updated on regulatory guidelines to ensure ongoing compliance with industry standards.

Compliance & Documentation: Developed SOPs, batch records, and assisted in audits to ensure GMP and regulatory compliance. Quality Control testing: Performed inspections, conducted torque/blister leak tests, and the tablet machine to maintain product integrity. Deviation Management & CAPA: Conducted root cause analysis, and implemented CAPA to enhance quality and compliance. Collaboration & Process: Worked with R&D, production, and regulatory teams, trained interns, and led efficiency improvements.

Regulatory Compliance & Quality Audits: Conducted rigorous inspections, process audits, and product evaluations to ensure strict adherence to GMP, SOPs, and industry regulations. Technical Documentation & Data Integrity: Maintained meticulous records of quality assessments, test results, and deviation reports, ensuring traceability and regulatory readiness. Process Optimization & Root Cause Analysis: Identified quality gaps, conducted statistical data analysis, and implemented corrective actions (CAPA) to enhance manufacturing efficiency. Cross-Functional Collaboration & Equipment Validation: Coordinated with production, R&D, and procurement teams to ensure raw material compliance, equipment calibration, and process validation.

Regulatory Compliance & Audit Preparation: Internal audit documentation was meticulously prepared, ensuring strict adherence to GMP, SOPs, and regulatory requirements. Quality Monitoring & Data Management: Testing activities were systematically documented, with defects tracked and performance metrics compiled using QA monitoring systems. Process Improvement & Risk Mitigation: Customer feedback was analyzed to identify quality gaps, while non-compliance issues were flagged and corrective actions were recommended. Equipment Validation & Compliance Monitoring: Routine equipment inspections, calibration checks, and compliance verifications were conducted to maintain operational efficiency.