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 opportunity 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
Job Description: Quality Assurance Executive
Location: Gurugram, Haryana
Experience Required: 0 - 3 Years (Freshers with solid 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