GxP Quality Engineer / Validation Test Engineer

Hi All .

Greetings from Orcapod consulting services

We have the openings for

Job Description GxP Quality Engineer / Validation Test Engineer

Experience

5–8 Years

Role Overview

We are looking for a GxP Quality Engineer / Validation Test Engineer to ensure the quality, compliance, traceability, and testing of a Pharma Quality Data Warehouse and analytics platform.

The solution includes quality dashboards, analytical views, APQR-related reports, inspection and audit reporting, and other quality data products. It operates in a GxP validated environment, making structured testing, traceability, documentation, evidence management, and data integrity critical to the role.

Key Responsibilities

• Define and execute the testing strategy for the Quality Data Warehouse.
• Review business and functional requirements for:
• Testability
• Completeness
• GxP impact
• Traceability
• Create and maintain:
• Test plans
• Test scenarios
• Test cases
• Test scripts
• Test evidence
• Requirement Traceability Matrix
• Validation-support documentation
• Perform end-to-end testing of:
• Data ingestion
• Transformation logic
• Snowflake data models
• dbt transformations
• Data Vault structures
• Power BI dashboards and reports
• Validate data from source through warehouse to reporting/analytics layers.
• Perform:
• Data reconciliation
• Data-quality testing
• Transformation-rule validation
• Regression testing
• Integration testing
• Negative testing
• UAT support
• Ensure Quality metrics, APQR reports, audit reports, and compliance dashboards accurately represent source data.
• Validate auditability and traceability of regulated data.
• Manage defects, including:
• Logging
• Classification
• Root-cause coordination
• Retesting
• Closure evidence
• Support inspection and audit readiness.
• Ensure changes to validated solutions follow established change-control processes.
• Participate in release-readiness reviews and validation assessments.
• Collaborate with Business Analysts, Data Engineers, Data Lead, Project Manager, and Quality stakeholders.
• Maintain testing and validation artifacts in Jira, Confluence, or applicable Quality systems.

Mandatory Skills

• Strong experience in GxP validation / Computer System Validation / Quality Engineering
• Experience testing data warehouse, data platform, or analytics solutions
• Strong SQL and data-validation skills
• ETL/ELT testing
• Data-reconciliation testing
• Requirements traceability
• Validation documentation
• Defect management
• Regression and integration testing
• Understanding of data integrity and auditability

GxP / Compliance Knowledge

Strong understanding of concepts such as:

• GxP
• Computer System Validation
• Risk-based validation
• Data Integrity
• ALCOA+ principles
• Audit trails
• Traceability
• Change control
• Evidence management
• Controlled release
• Deviation and defect management

Experience supporting Quality, inspection, audit, or compliance-oriented reporting is highly preferred. The program specifically supports inspection, audit, training-compliance, APQR, and GxP-aligned traceability use cases.

Technology Exposure

Experience validating solutions built using:

• Snowflake
• dbt
• Power BI
• Matillion
• Enterprise ETL / ELT platforms
• Data Vault architectures

Knowledge of Veeva and Oracle-based enterprise data sources is an added advantage.

Important Role Boundary

The role supports validation activities and ensures appropriate quality evidence is produced. Formal Quality-system ownership, process ownership, and validation sign-off remain with the appropriate customer Quality organization, consistent with the program operating model.

Ideal Candidate

A detail-oriented Quality Engineer who combines GxP validation knowledge with strong data-testing expertise, and who can challenge both functional requirements and technical implementations to ensure the resulting Quality Data Warehouse is accurate, controlled, traceable, and inspection-ready.

If interested please share your profile to [email protected]

Regards .