Hiring for IT CQA | Gurgaon Location

Key Accountabilities
- Execute and support Computerized System Validation (CSV) activities throughout the system lifecycle, including validation planning, risk assessment, protocol preparation, execution, review, reporting, change management, periodic review, and retirement activities.
- Review validation deliverables for computerized systems used in Manufacturing, Engineering, Quality Control, Quality Assurance, Warehouse, and other GxP functions to ensure systems remain in a validated state throughout their lifecycle.
- Design, develop, execute, and review manual and automated test scripts for GxP computerized systems, including Functional Testing, Integration Testing, System Testing, Regression Testing, User Acceptance Testing (UAT), and Performance Testing.
- Prepare and review validation documentation, including Validation Plans, User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Configuration Specifications, Risk Assessments, Requirement Traceability Matrices (RTM), IQ/OQ/PQ protocols,



Validation Summary Reports (VSR), and validation evidence.
- Ensure validation and computerized systems comply with applicable regulatory requirements and industry guidelines, including GxP, FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, MHRA, PIC/S, WHO, and company procedures.
- Perform Quality IT surveillance and periodic reviews of GxP computerized systems to ensure continued compliance with data integrity principles and applicable Quality Management System requirements.
- Review electronic records, raw data, metadata, audit trails, user management, electronic signatures, security settings, backup and restore activities, access controls, and other IT controls from a Quality and Data Integrity perspective.
- Participate in implementation, qualification, upgrades, migration, configuration changes, and decommissioning of computerized systems while ensuring compliance with CSV and Data Integrity

📌 Hiring For IT CQA Team Member | Gurgaon Location (Gurugram)
🏢 Walter Bushnell
📍 Gurugram