Quality Assurance Inspector- GLP

Job Title : Quality Assurance (QA) – Clinical Research

Experience : 8–10 years

Location : Indiranagar, Bangalore

Department : Quality Assurance

About the Role

MSCR is seeking an experienced QA professional with strong expertise in ICH-GCP and GLP principles to ensure the highest standards of quality and compliance across clinical research and laboratory operations. The ideal candidate will be well-versed in regulatory guidelines, clinical QA processes, and GLP compliance, with proven experience in audits, CAPA management, and continuous quality improvement initiatives.

Key Responsibilities

Clinical QA (ICH-GCP Focus)

• Develop and maintain ICH / GCP-compliant processes to control the quality of work and clinical studies at MSCR.
• Lead and manage internal quality audits, CAPA activities, and quality management reviews.
• Conduct study audits to ensure adherence to sponsor protocols, GCP, industry guidelines, and regulatory requirements.
• Identify non-conformances, recommend corrective measures, and drive risk-based continuous quality improvements.
• Perform vendor audits, collaborate with vendors and production support teams, and implement root cause analysis techniques.
• Deliver training sessions to MSCR staff on QA processes, compliance, and best practices.
• Support the review, evaluation, and implementation of new technology products and equipment.
• Review vendor-supplied data and quality records to ensure compliance with documentation standards.
• Provide QA expertise in special projects as required by management.

GLP Compliance & Audits

Documentation & SOP Management

Study Oversight

Regulatory & External Liaison

Training & Continuous Improvement

Requirements

Preferred Qualifications