At AlzaSyno Life Sciences , we are committed to delivering the highest standards of clinical research and regulatory compliance. As a leading CRO, we are looking for a meticulous and driven Quality Assurance Executive to strengthen our quality framework and ensure that our processes align with global regulatory standards, including the latest ICH GCP R3 guidelines.

This is an excellent chance for early-career professionals who are passionate about quality, compliance, and clinical data integrity. If you have a keen eye for detail and a desire to grow in the clinical research industry, we want to hear from you!

: Quality Assurance Executive

Location: Gurugram, Haryana

Experience Required: 0 - 3 Years (Freshers with strong academic backgrounds are welcome!)

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.

📌 Quality Assurance Executive (Gurugram)
🏢 AlzaSyno Life Sciences
📍 Gurugram