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

• Ensure compliance with OECD GLP principles and NGCMA guidelines across all studies.
• Plan, conduct, and report inspections (process, study-based, facility-based).
• Verify that study protocols, SOPs, and raw data adhere to GLP requirements.
• Maintain inspection schedules and records.

Documentation & SOP Management

• Review and approve SOPs related to study conduct, equipment, and data handling.
• Ensure secure archival of study data, reports, and records as per GLP requirements.
• Maintain GLP master files, training records, and compliance documents.

Study Oversight

• Audit study plans, amendments, and final reports for GLP compliance.
• Verify that deviations are documented, investigated, and resolved.
• Ensure that computerized systems used in studies meet GLP validation standards.

Regulatory & External Liaison

• Support NGCMA inspections, regulatory authority audits, and sponsor audits.
• Prepare compliance reports and respond to regulatory queries.
• Assist in accreditation and certification renewal processes.

Training & Continuous Improvement

• Conduct GLP training sessions for staff.
• Identify compliance gaps and propose corrective & preventive actions (CAPA).
• Support a culture of quality and integrity within the organization.

Requirements

• 8–10 years of experience in Quality Assurance within clinical research, pharmaceuticals, or life sciences.
• Strong knowledge of ICH-GCP guidelines, OECD GLP principles, NGCMA guidelines, and regulatory requirements.
• Proven experience in internal and external auditing (including vendor and regulatory audits).
• Hands-on experience in CAPA management and quality risk management methodologies.
• Ability to conduct root cause analysis and implement sustainable solutions.
• Strong understanding of Good Documentation Practices (GDP).
• Excellent communication, presentation, and training skills.
• Ability to work cross-functionally and manage multiple stakeholders.

Preferred Qualifications

• Prior experience in a Clinical Research Organization (CRO) or clinical trial QA environment.
• Experience in handling regulatory inspections (NGCMA, FDA, EMA, or other authorities).
• Knowledge of electronic QA systems and computerized system validation in line with GLP/GCP requirements.