Hi All .

Greetings from Orcapod consulting services

We have the openings for

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
- Solid 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 .

📌 GxP Quality Engineer / Validation Test Engineer (Bengaluru)
🏢 Orcapod Consulting Services
📍 Bengaluru