Bashyam Vijayaraj

About Bashyam Vijayaraj

Over 20 years of demonstrated expertise in initiating, developing, managing, and delivering comprehensive project management activities. Proven track record in validation processes, regulatory compliance, SAP implementation, and the successful deployment of ValGenesis VLMS(Validation Lifecycle Management System) and eLogbook software for medical device & pharmaceutical clients while ensuring compliance with regulatory standards. Recognized for driving innovation, managing complex regulatory environments, and seamlessly integrating cutting-edge technological solutions to support the medical device and pharmaceutical industries. Technical Evangelist with pioneering experience in diligently handling programs while managing governance, strategic & technical matters with a distinction of driving new initiatives and managing delivery of the programs while managing time, budget/cost and resources; collaborating with Senior Management and providing strategic direction on technology initiatives in line with the core organizational goals and business & profit objectives of the company. Excellent track record of spearheading service improvement programs for minimizing gaps in productivity and effectiveness in service delivery; strong exposure of single-handedly working on new business/proposals, proposing right engagement and presenting proposal to Senior Management and highlighting technical nitty-gritties & benefits for the organizations. People Engagement Professional, with an ability to foster a collaborative professional network with cross-functional teams while ensuring an employee-centric approach and addressing priorities as well as delegating and prioritizing complex tasks effectively to track and ensure compliance with deadlines. Feel free to drop a line at: b••••••••@yahoo.com

Experience

1. Project Manager Pmo

   Alcon

   Jan 2026 — Present · Batam, ID

Education

• Department of Technical Education (DOTE)

  Diploma, Mechanical Engineering

  1992 — 1995

• University of Madras

  Bachelor's degree, Mechanical Engineering

  1997 — 2001

Skills

• Fmea
• Quality Assurance
• Manufacturing
• Quality System
• Fda
• Cleaning Validation
• Gxp
• Sensors
• Iso 13485
• Cross-Functional Team Leadership
• Validation
• Computer System Validation
• Engineering
• Sop Development
• 21 Cfr Part 11
• Internal Audit
• Quality Control
• Corrective and Preventive Action (Capa)
• Failure Mode and Effects Analysis (Fmea)
• Process Improvement
• U.s. Title 21 Cfr Part 11 Regulation
• U.s. Food and Drug Administration (Fda)
• Process Validation
• Medical Devices
• Capa