Description

Required Technical Skill Set:

TrackWise Digital, TrackWise QMS, Salesforce Platform Administration, Complaint Management, Adverse Event Reporting, MuleSoft Interface Support

Must-Have

 8–12 years of experience, including strong L2/L3 support experience for TrackWise / TrackWise Digital QMS in regulated life sciences or medical device environments.

 Hands-on expertise in TrackWise Digital support for Global Complaint Handling, Post- Market Support, Complaints Management and Adverse Event Reporting processes.

 Good understanding of TrackWise configuration, Coordinator Configuration, workflow configuration, Team Access, Web Admin, PR Import / Selection Import, master data import and user access administration.

 Proven ability to troubleshoot record issues, stuck workflows, access issues, configuration defects, data issues, interface failures and recurring production defects within SLA.

 Strong technical knowledge of SQL, TrackWise database structure, Crystal Reports, data validation, root-cause analysis, change/problem management and stakeholder communication.

 Project Management, Team Management, Customer Interactions

Good-to-Have

 Working knowledge of TrackWise Digital on Salesforce platform, including roles/profiles, permission sets, page layouts, reports, dashboards, SOQL queries, Data Loader and Import Wizard.

 Experience supporting interfaces between TrackWise Digital and global source systems through middleware platforms such as MuleSoft.

 Knowledge of GxP, 21 CFR Part 11, validated-system support practices, audit readiness and controlled change/release management.

 Basic awareness of Windows Server, application monitoring, service health checks and infrastructure coordination for support issue resolution.

 Experience with ITSM tools such as ServiceNow for incident, problem, change, SLA tracking, ticket review and continuous improvement.

Responsibility of / Expectations from the Role

Serve as the Support Lead L2/L3 support contact for TrackWise Digital, restoring business-critical complaint handling and post-market quality services quickly and meeting agreed SLAs.

2 Lead incident triage, impact assessment, escalation, stakeholder communication, root-cause analysis and post- incident corrective/preventive actions.

3 Diagnose and resolve issues across TrackWise Digital records, workflows, access/security, configuration, reports, dashboards, interfaces and data layers.

4 Support Global Complaint Handling System processes covering complaint record creation, complaints management, post-market support and adverse event reporting.

5 Troubleshoot stuck records, workflow status issues, user access exceptions, master data import issues, PR Import / Selection Import issues and record lifecycle exceptions.

6 Coordinate with MuleSoft / integration teams for failed transactions, source-system data mismatches, complaint record creation issues and interface monitoring.

7 Prepare SQL queries, data analysis, validation evidence and reporting extracts required for ticket resolution, audit support and operational reviews.

8 Participate in change, release, validation and deployment activities, maintaining required documentation and traceability for a regulated QMS environment.

9 Collaborate with quality, regulatory, business process owners, integration, infrastructure, QA/validation and vendor teams to resolve production issues and deliver approved enhancements.

10 Provide guidance to junior support analysts, maintain knowledge articles / troubleshooting guides, conduct ticket trend analysis and recommend continuous improvements

Key Skills

Education

Any Graduate