Description

Own the Trackwise Quality compliance system as the primary business support lead.

Responsibilities

• Configure Trackwise and Coordinator components to align with business requirements.
• Manage workflow configurations and resolve issues when records become stuck.
• Develop web services and Crystal Reports to support system functionality.
• Manage PR Import Selection and utilize the Trackwise Team Access Web Admin component.
• Participate in project planning and all related technical meetings.

Required Skills

• 8-10 years of experience with Trackwise configuration and development.
• Proficiency in Crystal Reports development and design.
• Strong technical knowledge of SQL and Trackwise DB structure.
• Experience with Web Services development.
• Understanding of interfaces connected with Trackwise, such as SFDC, ETL, and SAP.
• Knowledge of GxP, 21 CFR Part 11, and Life Sciences domain requirements.
• Familiarity with business processes including Complaint, Deviation, Audit, and CAPA.
• Understanding of SDLC, Change Management, and Problem Management.
• Basic knowledge of Windows Server.

Preferred Skills

• Experience in customer-facing roles analyzing requirements and mapping business operations.
• Ability to collaborate with offshore teams and translate requirements into functional specifications.

Key Skills

Education

Any Graduate