Manish Dharmadhikari Email & Phone Number

Pune, MH, IN

Plano, Texas, US

• Managed full lifecycle implementations of SAP MM, PP, QM, and PS for Fortune 500 clients in
• Implemented SAP PS for an aerospace manufacturer, enhancing project tracking and reducingcost overruns by 18%.
• Migrated legacy systems to S/4HANA for a global medical device leader, aligning processes withFDA and ISO 13485 requirements.
• Designed and configured integrated production planning and material management workflows,reducing downtime by 15%.
• Configured SAP QM for pharma clients, ensuring seamless compliance with GMP and regulatoryrequirements

Amsterdam, Noord-Holland, NL

• FDA Site Readiness Project: Led the implementation of the FDA Site Readiness Project, known as Project Sunrise, ensuring compliance with regulatory standards and readiness for inspections.
• Cross-Functional Collaboration: Drove corrective and preventive actions (CAPAs) by collaborating with all levels of the organization and cross-functional teams, fostering a culture of quality and accountability.
• Defect Analysis Integration: Integrated Defects on Arrival and Service Defects analyses into the production process, enabling continuous improvements and enhancing product reliability.
• CAPA Management: Oversaw CAPA tracking, coordination, and closure, along with managing change controls and deviations to ensure effective resolution and compliance.
• Designed and deployed Google Dialogflow ES bots for enterprise clients, enhancing customersupport efficiency by 30% across multiple channels.
• Developed and implemented conversational flows of new voice/chat bots for our businessunits with high level of complexity.

GB

• QMS Strategy Advisory: Advised clients in the Automotive, Aerospace, and Medical Device sectors on Quality Management System (QMS) strategies for effective program management, including creation of SOPs, WI, Process.
• eQMS and DQMS Implementations: Successfully implemented eQMS and DQMS systems for clients.
• Comprehensive Advisory Services: Provided expert advisory services in key areas such as manufacturing planning, strategic initiatives, lean manufacturing, warehouse and materials management, product lifecycle.
• Designed and Deployed Enterprise-Grade Conversational AI Solutions:Created advanced chatbot and voice assistant systems using Google Dialogflow ES Fortune 500 clients,automating customer support and operational.
• End-to-End Conversational Design:Crafted user-centric conversational flows, intent structures, and response designs, enhancinguser engagement and driving 30% faster resolution times.
• Multi-Channel Deployment:Implemented AI-driven virtual assistants across web, mobile apps, WhatsApp, FacebookMessenger, and voice platforms like Google Assistant and Alexa.

Birmingham, West Midlands, GB

• Automated Quality Management System Assistance for Manufacturing:Designed a Google Dialogflow ES-powered virtual assistant to provide real-time support for QMSprocesses, including document retrieval, compliance checks.
• CAPA Workflow Automation:Designed a Dialogflow ES virtual assistant to streamline Corrective and Preventive Action (CAPA)workflows, guiding users through root cause analysis and action plan updates. Improved.
• Policy and Procedure Design: Developed and implemented policies and procedures utilizing Kanban principles for production and warehouse areas, optimizing workflow and inventory management.
• Productivity Improvement Leadership: Led a team of six team leaders to achieve a 20% increase in productivity while significantly enhancing the employee learning curve through targeted training and development.
• Aerospace Product Classification Roadmap: Assisted the Plant Head and senior management in creating a comprehensive roadmap for the Scomet 5 classification of aerospace products, ensuring alignment with industry.
• Regulatory Compliance Review: Conducted thorough reviews of ITAR and EAR regulatory compliance during AS9100 audits, providing detailed reporting on compliance status and identifying areas for improvement.

Lewisville, TX, US

• End-to-End QMS Digital Transformation:Led the development of an enterprise-wide conversational AI system using Google Dialogflow ES toenhance the QMS for high-volume electronics manufacturing, driving a 25% increase.
• Real-Time Quality Issue Management Bot:Designed and deployed a Dialogflow ES-based virtual assistant to provide real-time support forquality control teams, facilitating instant access to inspection protocols.
• Interactive Audit Preparation and Compliance Guide:Developed an AI-powered chatbot to support plant audits, ensuring staff had on-demand accessto compliance documentation, standard operating procedures, and historical.
• CAPA (Corrective and Preventive Action) Support Bot:Deployed an AI-powered assistant for managing CAPA workflows, guiding teams through rootcause analysis and solution implementation. Integrated with SAP PS to ensure.
• Quality and Environmental Management Systems Implementation: Successfully designed and implemented Quality Management (ISO 9001:2015) and Environmental Management Systems (ISO 14001:2015), achieving certification for.
• CAPA Leadership Roles: Served in multiple capacities including CAPA Owner, CAPA Coach, CAPA Approver, and Chair of the Change Review Board (CRB), facilitating cross-functional team reviews for CAPA approvals.

Dallas, TX, US

• Worked in cross-functional teams to drive ‘5S Project’ in warehouse resulting in cycle time reduction of 15%.
• Provided recommendations for layout changes in warehouse and simulated layout using table-top exercise to get approval from stakeholders of the project by presenting possible changes and addressing cause and effect.
• Performed material flow simulation using table-top exercise and addressed weekly meetings about warehouse design changes.
• Conducted analysis using Microsoft Access and prepared graphic presentations of 5S quarterly audits data.
• Provided effective engineering support by communicating progress of project to stakeholders associated with various engineering activities including supervisors, managers, and senior management to solve ongoing problems.

Hamburg, DE

• Analyzed operations such as production, overhaul, maintenance, repair to improve quality and developed procedures and processes during value stream mapping project utilizing lean manufacturing methodologies such as 4Q.
• Trained 60 new hired employees on lean/ Six Sigma methodology concepts such as 5S, PDCA, Kaizen, Kanban, Poka- Yoke.
• Supporting development and implementation of methods for sampling, inspection, testing and evaluation of products.
• Audited manufacturing and engineering processes and provided recommendations to improve KPIs and increased throughput. Designed a KPI of ‘%C&A’ as a part of CAPA identification and worked with specific departments to.
• Led ‘Bushings Best Practices’ project to facilitate manufacturing cost reduction by results driven data analysis for batch production and performed Make Vs Buy Analysis, Vendor Management, using GD&T and data analysis.

Richardson, Texas, US

• Performed accounting functions and maintained cost center for employees.
• Handled reimbursement for employees and documentation related to reimbursement.
• Data analysis and data compilation for all accounts of the employees.
• Managed and coordinated events by sending e-vites, printing badges and tent cards.

Chertsey, Surrey, GB

• Performed accounting functions.
• Provided customer service.

Master Of Science (Msc), Systems Engineering And Management

Bachelor Of Technology (B.Tech.), Mechanical Engineering

Sap Pp Hana, Sap S/4 Hana