Trackwise Digital SME

Vaisesika Systems Consulting Inc.

United States

3 months ago

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Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Experienced

Experience required

4 years minimum

Working hours

Regular working hours

Job source

dice.com

Tech stack

Application Programming Interfaces (APIs) Agile Methodology Crystal Reports (Reporting Software) Data Governance Laboratory Information Management Systems Systems Development Life Cycle SQL Databases Systems Integration Web Services Iq/oq/pq Information Technology Trackwise

+2 more

GXP User Administration

Job description

Seeking an experienced TrackWise Digital SME to lead administration, configuration, validation, and enhancement of the TrackWise Digital platform in a GxP-regulated environment., * Manage TrackWise Digital administration, enhancements, and releases.

Lead implementation, validation, and compliance activities.
Support integrations, user management, data governance, and audit readiness.
Collaborate with business, IT, validation teams, and vendors as the TrackWise SME.

Requirements

4-6+ years of hands-on TrackWise Digital experience
TrackWise Administration, Configuration & Validation
CAPA, Deviations, Change Control, Workflow Configuration
GxP, GMP, FDA, 21 CFR Part 11 Compliance
Validation Lifecycle (IQ/OQ/PQ/UAT)
APIs, Web Services & System Integrations
ERP, LIMS, MES Integrations
SQL, Crystal Reports (preferred)
SDLC & Agile Methodologies, Education: Bachelor’’s Degree in Computer Science, IT, or related field.