Quality Assurance Executive

**J*_**ob Description: Quality Assurance Executive*_

Location: Gurugram, Haryana
Experience Required: 1- 3 Years

Roles & Responsibilities:

• Conduct audits of clinical trial processes, data management activities, and vendor operations to ensure compliance with ICH-GCP, applicable regulatory requirements, and SOPs.
• Support in the development, review, and implementation of Quality Management Systems (QMS) and Standard Operating Procedures (SOPs).
• Perform process and system validation reviews, ensuring data governance principles (as per ICH GCP R3 updates) are followed.
• Assist in internal and external audit preparation, including hosting sponsor audits and regulatory inspections.
• Manage the CAPA (Corrective and Preventive Action) system—tracking, reviewing, and ensuring timely closure of quality issues and deviations.
• Contribute to risk-based quality management (RBQM) initiatives, reviewing critical-to-quality (CtQ) data and key risk indicators (KRIs).
• Review clinical study documentation, including Data Management Plans (DMPs), eCRFs, and study reports.
• Provide quality oversight and training on GCP and quality compliance to cross-functional teams.

Key Skills Required

✅ Knowledge of GCP & Regulatory Guidelines: Sound understanding of ICH-GCP, Schedule Y, and familiarity with the latest ICH GCP R3 updates (Data Governance, RBQM, etc.).
✅ Audit & Compliance: Basic understanding of audit methodologies, CAPA management, and compliance monitoring.
✅ Quality Management Systems (QMS): Experience or academic exposure to SOP development and quality frameworks.
✅ Clinical Research Knowledge: Understanding of clinical trial processes, including Data Management, Biostatistics, and Medical Writing.
✅ Analytical & Problem-Solving: Strong analytical skills with a meticulous, detail-oriented approach to documentation and review.
✅ Communication: Excellent written and verbal communication skills to collaborate effectively with internal teams and sponsors.
✅ Technical Skills: Proficiency in MS Office (Word, Excel, PowerPoint) and familiarity with EDC systems is a plus.

Pay: ₹35,000.00 - ₹45,000.00 per month

Work Location: In person