Quality Assurance Associate (Bengaluru)

Quality Assurance Associate (Bengaluru)

08 Sep
|
MS CLINICAL RESEARCH
|
Bengaluru

08 Sep

MS CLINICAL RESEARCH

Bengaluru

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 Good 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 require

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

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