Sr. TrackWise Consultant

About the role

You will be responsible for identifying, developing, and implementing software solutions. This includes working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. You will also manage projects and software throughout their respective lifecycles.

Responsibilities

• Directly participate in the analysis, configuration, modification, and implementation of IT Business Systems.
• Demonstrate strong communication, analytical, and problem-solving skills to identify, communicate, and resolve system issues to maximize IT system benefits.
• Analyze the effectiveness and efficiency of existing business processes and business requests, recommending solutions using system standards and best practices.
• Conduct analysis of system specifications and configurations, developing appropriate documentation.
• Create detailed specifications and process flows to guide application developers.
• Perform solution designing, requirements definition, functional design, testing, and implementation of IT solutions.
• Support, assist, and train users on new or modified system configurations, highlighting impacts on business processes.
• Maintain IT Business system integrity, including application notes, system upgrades, changes, and user updates.
• Work closely with onsite teams, offshore teams, managers, and executives to ensure the release of high-quality solutions.
• Comply with regulatory and change control requirements and processes.
• Perform business requirements gathering, analysis, and business system design for TrackWise-based applications.
• Create workflows, business rules, TWC automation, notifications, and migrate updates.
• Develop TrackWise WebServices (Search/Populate/Transfer) using OWS/IWS.
• Create and implement Crystal Reports.

Requirements

• Minimum 8 years of TrackWise System Analysis experience.
• Experience in the Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.).
• Knowledge and understanding of CAPA and Complaints processes.
• Exposure to integration with SAP systems preferred.
• Experience with TrackWise Quality View is preferred.
• Experience working with business end users, gathering requirements, and building detailed functional design specifications.
• Ability to work on multiple projects concurrently with minimal supervision or guidance.
• Familiarity with Software Development Lifecycle (SDLC) processes.
• Strong verbal and written communication skills.
• Contribute to team-building measures like Knowledge Management & Mentoring.

Skills

• TrackWise Configuration
• TrackWise Web Service Development
• TrackWise Crystal Reports Development
• Java programming