Job Title: Quality Assurance (QA) Associate – Clinical Trials Experience: 2–4 years Location: Indiranagar, Bangalore Department: Quality Assurance Employment Type: Full-time About the Role We are seeking a detail-oriented and quality-focused QA Associate – Clinical Trials to join MS Clinical Research (MSCR). The candidate will support the implementation and maintenance of quality and compliance standards across clinical research operations. The ideal candidate should have a good understanding of ICH-GCP, clinical trial processes, regulatory requirements, Good Documentation Practices (GDP), audits, CAPA, and quality management systems . The role will involve working closely with cross-functional teams to identify quality issues, ensure compliance, and support continuous improvement initiatives. Key Responsibilities Support the development, implementation, and maintenance of ICH-GCP-compliant processes, SOPs, and quality systems . Assist in planning and conducting internal quality audits, study audits, and vendor audits .



Review clinical trial documentation and records for compliance with protocols, SOPs, GCP, and applicable regulatory requirements. Identify and document non-conformances, deviations, and quality issues and support appropriate corrective and preventive actions. Assist in CAPA management , including tracking actions, monitoring timelines, and verifying effectiveness. Support root cause analysis and risk assessment for quality-related issues. Assist in maintaining and reviewing quality records, audit reports, CAPA records, and other QA documentation . Ensure adherence to Valuable Documentation Practices (GDP) across clinical research activities. Support preparation for internal, sponsor, vendor, and regulatory audits/inspections . Participate in quality management reviews and follow up on action items. Review vendor-supplied documentation and quality records for completeness and compliance. Conduct or support QA and GCP training sessions for employees as req

📌 Quality Assurance Associate (Karnataka)
🏢 MS CLINICAL RESEARCH
📍 Karnataka