Project Role : Custom Software Engineer
Project Role Description : Design, build and configure applications to meet business process and application requirements.
Must have skills : TrackWise Quality Management Software
Good to have skills : NA
Minimum 3 Year(s) Of Experience Is Required
Educational Qualification : 15 years full time education
Summary:
As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. A typical day involves collaborating with team members to understand project needs, developing innovative solutions, and ensuring that applications function seamlessly to support business objectives. You will engage in problem-solving discussions and contribute to the overall success of the projects you are involved in.
Roles & Responsibilities:
- Lead or support TrackWise system implementation, upgrades, and validation activities.
- Perform installation, configuration, and environment setup (Dev, QA, Prod) for TrackWise.
- Manage TrackWise application administration, including user access, security, roles, and privileges.
- Configure and maintain TrackWise workflows, records, processes, and forms as per business requirements.
- Collaborate with business analysts and QA teams to design and document functional and technical specifications.
- Support integration activities with external systems such as SAP, ServiceNow, or LIMS.
- Perform application troubleshooting, issue resolution, and root cause analysis.
- Coordinate with vendors (e.g., Sparta Systems) for patch deployment, upgrades, and licensing.
- Prepare and maintain system documentation, SOPs, validation deliverables, and change control records.
- Provide user training and post-go-live support for TrackWise users.
- Ensure compliance with GxP, 21 CFR Part 11, and other regulatory requirements
Professional & Technical Skills:
- Strong hands-on experience in TrackWise (versions 8.x / 9.x / 10.x / EQMS / Cloud).
- Expertise in TrackWise configuration tools Process Configuration Tools (PCT), Administrative tools, and Quality Event management.
- Experience in Crystal Reports, SQL Server, and Oracle database for report generation and data analysis.
- Knowledge of TrackWise Web Services (SOAP/REST API) for integrations.
- Experience with TrackWise Digital / QualityOne (Salesforce platform) is an added advantage.
- Strong understanding of Validation Life Cycle URS, FS, DS, IQ, OQ, PQ.
- Familiarity with Windows Server, IIS, and application deployment.
- Hands-on experience with TrackWise upgrade/migration projects (e.g., from on-premise to cloud).
- Exposure to TrackWise integration with ERP, CRM, or QMS tools.
- Good knowledge of GxP, CSV, and audit trail requirements.
- Excellent analytical, documentation, and communication skills.
Additional Information:
- The candidate should have minimum 3 years of experience in TrackWise Quality Management Software.
- This position is based at our Chennai office.
- A 15 years full time education is required.
, 15 years full time education