Lead - Process Excellence - Trackwise

Job Description

We are looking forward to hire Trackwise Professionals in the following areas : Job Summary: We are seeking a skilled and detail-oriented TrackWise Specialist to join our Quality Systems team. The ideal candidate will have hands-on experience with the TrackWise Quality Management System (QMS) and will be responsible for configuring, maintaining, and supporting TrackWise workflows and modules to ensure compliance with regulatory requirements and internal quality standards. Key Responsibilities: Configure and maintain TrackWise workflows, forms, and reports. Collaborate with cross-functional teams to gather requirements and implement QMS solutions. Perform system administration tasks including user access management, troubleshooting, and upgrades. Support validation activities including IQ/OQ/PQ documentation and execution. Provide training and support to end-users on TrackWise functionalities. Ensure compliance with FDA, ISO, and other regulatory standards. Participate in audits and inspections as a TrackWise subject matter expert (SME). Required Skills: 5+ years of experience working with TrackWise QMS (preferably versions 8 or higher). Strong understanding of quality processes such as CAPA, Deviations, Change Control, and Audits. Experience with system validation in a regulated environment (GxP, 21 CFR Part 11). Familiarity with SQL, Crystal Reports, or other reporting tools is a plus. Excellent problem-solving, communication, and documentation skills. Our Hyperlearning workplace is grounded upon four principles Flexible work arrangements, Free spirit, and emotional positivity Agile self-determination, trust, transparency, and open collaboration All Support needed for the realization of business goals, Stable employment with a great atmosphere and ethical corporate culture