Location:PAN INDIA

Type:Contractual

EXP:5+ YEARS

Key Responsibilities

Quality Management Process Support

Support end-to-end Quality Management processes within Veeva Vault Quality.

Manage deviations, CAPAs, change controls, complaints, audits, inspections, and training records.

Collaborate with business stakeholders to improve quality processes and compliance.

Ensure adherence to GxP and industry regulations.

Veeva Vault Configuration & Administration

Configure and maintain Veeva Vault Quality applications.

Manage workflows, lifecycles, security profiles, permissions, and document types.

Support system enhancements, upgrades, and release activities.

Perform impact assessments and implement configuration changes.

Quality Systems Implementation

Participate in Veeva Vault Quality implementation projects.

Gather business requirements and translate them into system solutions.

Prepare functional design documents and configuration specifications.

Conduct workshops and user training sessions.





Validation & Compliance

Support Computer System Validation (CSV) activities.

Develop validation documents including IQ, OQ, PQ, RTM, and test scripts.

Ensure compliance with FDA 21 CFR Part 11, Annex 11, GAMP 5, and GxP requirements.

Assist during regulatory inspections and audits.

Testing & Deployment

Prepare and execute system integration testing (SIT) and user acceptance testing (UAT).

Coordinate defect management and resolution.

Support production deployments and hypercare activities.

Data Migration & Integration

Support migration of quality data and documents into Veeva Vault.

Help integrate Vault Quality with ERP, LIMS, MES, and other enterprise systems.

Troubleshoot integration and data quality issues.

IF COMFORTABLE WITH C2H,PLEASE SEND RESUME AT [email protected]

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