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 required.
- Collaborate with Clinical Operations, Medical Writing, Data Management, Regulatory, and other relevant teams to address quality and compliance-related matters.
- Support the implementation of risk-based quality management and continuous improvement initiatives.
- Assist in evaluating and implementing new systems, tools, and technologies relevant to clinical quality processes.
- Maintain awareness of changes in applicable ICH-GCP guidelines, regulatory requirements, and industry best practices.
- Perform other QA-related activities as assigned by management.

Requirements

- 2–4 years of experience in Quality Assurance within clinical research, pharmaceuticals, CROs, or the life sciences industry.
- Good understanding of ICH-GCP guidelines, clinical trial processes, and applicable regulatory requirements.
- Exposure to internal, study, sponsor, or vendor audits.
- Basic to intermediate knowledge of CAPA, deviation management, non-conformance management, and quality risk management.
- Understanding of root cause analysis and problem-solving methodologies.
- Valuable knowledge of Good Documentation Practices (GDP).
- Experience in reviewing clinical research documentation and quality records.
- Strong attention to detail and ability to identify compliance and documentation gaps.
- Good written and verbal communication skills.
- Ability to work collaboratively with cross-functional teams and manage multiple tasks effectively.
- Proficiency in MS Office and familiarity with electronic quality management or clinical trial systems is preferred.

Preferred Qualifications

- Prior experience in a CRO or clinical research QA environment.
- Exposure to GCP audits, sponsor audits, vendor audits, or regulatory inspections.
- Experience with electronic Quality Management Systems (eQMS) or other clinical research quality systems.
- Knowledge of current ICH-GCP and regulatory expectations.
- Certification or formal training in GCP, Clinical Research, Quality Management, or Auditing will be an added advantage.

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