We are seeking a seasoned TrackWise Digital Consultant with hands-on experience in implementing, configuring, supporting, and enhancing TrackWise Digital solutions within regulated Life Sciences and Pharmaceutical settings.
The candidate should possess solid expertise in Quality Management processes, validation activities, GxP compliance, and stakeholder management.
Key Responsibilities
Configure and support TrackWise Digital applications and workflows.
Gather business requirements and translate them into scalable TrackWise solutions.
Implement and maintain modules including:
CAPA
Deviations
Change Control
Audits
Complaints
Supplier Quality
Perform system configuration, workflow setup, roles, permissions, and business rules.
Support production issues,
incident management, service requests, and enhancements.
Prepare validation deliverables and documentation.
Work closely with Quality, Compliance, and Business stakeholders.
Participate in requirement analysis, testing, deployment, and post-production support.
Ensure compliance with GxP and 21 CFR Part 11 regulations.
Mandatory Skills
TrackWise Digital (TWD)
TrackWise Workbench
Quality Management Systems (QMS)
CAPA
Deviation Management
Change Control
Audit Management
Complaint Management
GxP
GMP
21 CFR Part 11
Validation / CSV