Quality Assurance Associate

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.
• Good 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.