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▷ [01 / 10 / 2025] Quality Assurance Inspector- GLP

MS CLINICAL RESEARCHBengaluru, Karnataka, India

5 hours ago

Job description

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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Quality Inspector • Bengaluru, Karnataka, India