Sr. TrackWise Consultant : 26-02120

Senior Track Wise Consultant

We are seeking a Senior Track Wise Consultant to support the design, configuration, enhancement, and implementation of Track Wise Quality Management System (QMS) solutions for a leading medical device organization. The ideal candidate will have extensive experience with Track Wise configuration, workflow automation, web service development, Crystal Reports, and Java development, along with a strong understanding of regulated environments, CAPA, Complaints, and compliance standards such as FDA 21 CFR Part 11, GxP, and GAMP.

Key Responsibilities:

• Analyze business requirements and design scalable Track Wise solutions to support Quality Management processes.
• Configure Track Wise workflows, business rules, forms, notifications, automation, and system enhancements.
• Develop and maintain Track Wise Web Services (OWS/IWS) including Search, Populate, and Transfer services.
• Design, develop, and implement Crystal Reports for quality and compliance reporting.
• Perform solution design, system configuration, functional testing, validation support, deployment, and production support.
• Collaborate with business users to gather requirements and translate them into detailed functional specifications.
• Troubleshoot application issues, perform root cause analysis, and implement system improvements.
• Support software lifecycle management including upgrades, change control, documentation, and user training.
• Partner with onsite and offshore teams to deliver high-quality, compliant software solutions.
• Ensure adherence to SDLC processes, regulatory requirements, and quality system standards.

Must-have

Skills:

• 8+ years of hands-on Track Wise System Analysis and Configuration experience.
• Strong expertise in Track Wise Configuration, workflows, business rules, TWC automation, and notifications.
• Experience developing Track Wise Web Services (OWS/IWS) including Search, Populate, and Transfer services.
• Strong experience developing Crystal Reports.
• Solid Java programming experience.
• Experience supporting CAPA, Complaints, Quality Management Systems (QMS), and regulated business processes.
• Strong understanding of FDA 21 CFR Part 11, GxP, GAMP, and software validation requirements.
• Experience gathering business requirements and preparing functional design documentation.
• Familiarity with SDLC methodologies, testing, deployment, and production support.
• Excellent analytical, troubleshooting, communication, and stakeholder management skills.

Nice-to-have

Skills:

• Experience integrating Track Wise with SAP.
• Experience with Track Wise Quality View.
• Medical Device or Life Sciences industry experience.
• Experience working with validation documentation and regulated software implementations.
• Experience mentoring team members and contributing to knowledge management initiatives.