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.

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