QMS Support Lead

• Application skill- Trackwise + Qumas + Master Control
  Working Experience in configuration, which includes TrackWise workflow, Group categories, Config forms, Admin queries, TW Coordinator configuration etc.
• Experience in utilities like PR Import, Selection Import, Person Import and Entity Import. Debugging and creating application inbound and outbound web services using JAVA.
• Experience in crystal report issue fixation and support activities. Creation and execution of validation (IQ,OQ, PQ) test script for functionality.
• Experience in Configuration and enhancements in Supplier Quality Management Module- CAPA system, Change Controls, Deviations, Audit Management, Manage Configuration and reporting templates in Asset Management and EHS applications- Carry out upgrade activities.
• Understanding of Global Core Quality Processes (CQP): gCMPLT, gTrend, gDR, gLIR, gCAPA, gCCM. gTracking
  
  

Other Technical skills

• Database knowledge and Skilled in SQL queries
• Experience in data structures and object-oriented designs in Java programming language
• Experience in UI development with Java Swing clients and web technologies
• Familiarity with common development tools as Eclipse, Maven
• Experience with development on Web Services,
  
  
• Experience in Troubleshoot the Application related issues in production & Non- production environments, Perform impact analysis of business issues at L1 , L2, L3 levels.

• Hands-on experience in ticketing tools like BMC Remedy Service Management, Service Now , Tools group and JIRA
  
  

Good to have:

• Domain Knowledge-Pharmaceutical/LS, 21 CFR Part 11, well versed with ITIL Process Knowledge
  Experience

Must have:

Candidates must have thorough Experience in supporting TrackWise Modules.