Solvex Solutions
Website:
solvex-solutions.com
Job details:
Positions:
- Test Lead (GxP)
- Test Engineer
Contract: 1 year (Remote)
Responsibilities:
Position-1: Test Lead (GxP)
- Responsible for validating migrated OT applications against GxP compliance requirements,
- Ensuring data integrity and adherence to regulatory standards.
- Executes and documents qualification protocols (IQ/OQ/PQ) to maintain system compliance throughout migration.
- Prepare Test document and strategy for IQ/PQ/OQ test documents.
- Coordinate OT compliance/validation readiness activities (e.g., ensuring required GxP/CSV evidence, test results, and SOP adherence are captured and filed).
- GxP/CSV awareness for application changes (evidence coordination, test result documentation, IQ/OQ template coordination).
- Prepare evidence capture checklist aligned to GxP/CSV needs for application changes (what evidence is required, where stored, who signs).
- Prepare Change control templates/site SOPs and GxP expectations where applicable.
- Capture GxP / CSV relevance: validation category, evidence expectations, approval checkpoints.
Position-2: Test Engineer
- Designs and executes test cases for OT apps.
- Execute test cases for OT systems and basic application usability testing
- Assurance as per the local quality standards
- Support in preparing the test documents
Click on Apply to know more.