Supply Chain Project Management

Bhargav Gajera

Certified Lean Six Sigma Green Belt

857-***-**** ******.*@************.*** LinkedIn EDUCATION

Northeastern University Boston, MA Sept 2022- May 2024 Master of Science in Engineering Management

Courses: Deterministic Operations Research, Engineering Probability and Statistics, Lean Concepts and Applications, Supply Chain Engineering, Product Development for Engineers, Engineering Project Management, Financial Management Gujarat Technological University Ahmedabad, India July 2016- Aug 2020 Bachelor of Engineering in Mechanical Engineering

SKILLS

Data Analysis: MS Excel (Pivot, Macros, VBA, Linear Programming), Tableau, SQL, Python, R Software: MS Office (Word, PowerPoint, Access, Project, Outlook), Minitab, AutoCAD, SolidWorks Soft-Skills: Leadership, Teamwork, Communication, Time Management, Strategic, ISO 13485, ISO 9001, ISO 14971, ISO 10993 Core Competencies: Root Cause Analysis, Demand Planning, Layout Designs, Procurement, Logistics, Inventory Management, Forecasting, Supply Chain Strategy, Continuous Improvement, Data Analysis, Data Visualization, Project Management, 5S, Kaizen Experience

Infoline International GJ, India Sept 2020 – July 2022 Quality Engineer

• Executed CAPA strategies that addressed deviation findings, resulting in a 25% reduction in process failures and enhancing overall process reliability.

• Produced comprehensive deviation reports detailing root causes and CAPA plans, improving stakeholder communication and reducing investigation times by 15%.

• Streamlined deviation documentation processes by implementing new systems for tracking corrective actions and preventive measures, leading to a 20% increase in traceability and transparency.

• Conducted impact analyses during deviation investigations, identifying potential effects on product quality and patient safety, which minimized regulatory risks by 30%.

• Led risk assessments for deviations, recommending and implementing mitigation strategies that decreased potential product quality issues by 40%.

• Assessed product quality impacts during deviation investigations, reducing the risk of product recalls by 25% and ensuring patient safety and regulatory compliance.

• Spearheaded continuous improvement initiatives that cut down deviation occurrences by 20%, optimizing manufacturing processes, and boosting product quality.

Welscon Lifescience GJ, India May 2019 – Dec 2019 Quality Engineer Co-op

• Evaluated and verified deviation reports to ensure accuracy, aligning with regulatory requirements and internal quality standards.

• Administered validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes, ensuring consistent performance and compliance.

• Evaluated deviation trends, conducted risk assessments, and proposed mitigation strategies to safeguard product quality and safety.

• Supervised the Quality Management System (QMS), facilitated SOP development and upheld cGMP guidelines through comprehensive internal and external audits.

• Organized regulatory inspection preparations by ensuring thorough documentation of deviation investigations and adherence to regulatory standards.

• Performed batch record reviews and investigations, implementing corrective actions to uphold GMP standards. PROJECT WORK DETAILS

Enhancing the Efficiency and Applicability of Root Canal Treatment Instruments: Design and Analysis” July 2019 – Aug 2020

• Improved RCT file usability by optimizing essential parameters, resulting in a 60% increase in usability and a 23% reduction in dentist operational costs per operation.

• Implemented RCT file parameters in SolidWorks for 3D modeling and ANSYS simulation to optimize design and compare data of the existing RCT file, by using mechanical engineering principles of rake angle and helical angle and by implying the designing principles.

Optimization of Quality Systems and Deviation Management Dec 2022 – Jan 2023

• Revamped the batch record review process, boosting accuracy and completeness by 25%, which reduced documentation errors by 15% and enhanced regulatory compliance.

• Conducted comprehensive reviews of Quality Management System (QMS) processes, identifying and implementing enhancements that improved overall process efficiency by 35%.

• Analyzed deviation trends and performed risk assessments, leading to the identification and mitigation of potential impacts on product quality, resulting in a 20% reduction in deviation-related risks.

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