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Lead - Process Excellence - Trackwise Job

Lead - Process Excellence - Trackwise Job

YASH TechnologiesPune, IN
16 days ago
Job description

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.
  • At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment. We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale.

    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
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    Excellence Trackwise • Pune, IN