Bachelor's degree with over 8 years of experience in designing and developing solutions in Trackwise
• Proven track record of successfully completing Trackwise project implementations, including stages such as discovery, design, development, testing, and deployment.
• Experience working in a GMP environment, 5+ years in an IT Systems Role.
• Expert knowledge of GMP Quality Management to include CAPA/Deviation, Lab Exception, Product Complaint, Audit, and Supplier Management.
• SDLC/GAMP, Business Analysis, and Enterprise Systems Management. General knowledge of GxP Quality Processes and Systems (GMP, GLP, GCP, GVP, GDP)
• Familiarity with other enterprise systems and modules such as ERP, SCM, and PLM, which complement quality management functions.
• Certification in Trackwise or Equivalent Experience is required.
• In-depth knowledge of Quality Management business processes within a regulated environment, including CAPA, Change Control, Audits, and Deviations.




• Extensive knowledge of Trackwise and other QMS modules, with additional familiarity with ERP, SCM, and PLM systems.
• Solid oral and written communication skills, effective presentation and negotiation abilities, and experienced in managing multiple presentation scenarios.
• Proven ability in handling multiple responsibilities, including system configuration, coding, system testing, end-to-end testing, and production support.
• Experience in all phases of project life cycle from analysis and design to implementation and testing.
• Excellent analytical, problem-solving, and interpersonal skills.
• Strong team player with excellent collaboration skills.
• Strong Knowledge of SDLC, GAMP, and Computer Systems Validation in a GxP Environment
• Agile Methodology using Jira, creating Epics, and writing Jira Stories.

📌 Techno Functional Analyst (India)
🏢 Teamlease Digital Private
📍 India