Job Title: Quality Assurance – GLP
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)
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Develop and maintain ICH/GCP-compliant processes to control the quality of work and clinical studies at MSCR.
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Lead and manage internal quality audits, CAPA activities, and quality management reviews.
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Conduct study audits to ensure adherence to sponsor protocols, GCP, industry guidelines, and regulatory requirements.
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Identify non-conformances, recommend corrective measures, and drive risk-based continuous quality improvements.
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Perform vendor audits, collaborate with vendors and production support teams, and implement root cause analysis techniques.
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Deliver training sessions to MSCR staff on QA processes, compliance, and best practices.
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Support the review, evaluation, and implementation of new technology products and equipment.
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Review vendor-supplied data and quality records to ensure compliance with documentation standards.
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Provide QA expertise in special projects as required by management.
GLP Compliance & Audits
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Ensure compliance with OECD GLP principles and NGCMA guidelines across all studies.
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Plan, conduct, and report inspections (process, study-based, facility-based).
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Verify that study protocols, SOPs, and raw data adhere to GLP requirements.
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Maintain inspection schedules and records.
Documentation & SOP Management
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Review and approve SOPs related to study conduct, equipment, and data handling.
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Ensure secure archival of study data, reports, and records as per GLP requirements.
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Maintain GLP master files, training records, and compliance documents.
Study Oversight
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Audit study plans, amendments, and final reports for GLP compliance.
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Verify that deviations are documented, investigated, and resolved.
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Ensure that computerized systems used in studies meet GLP validation standards.
Regulatory & External Liaison
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Support NGCMA inspections, regulatory authority audits, and sponsor audits.
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Prepare compliance reports and respond to regulatory queries.
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Assist in accreditation and certification renewal processes.
Training & Continuous Improvement
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Conduct GLP training sessions for staff.
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Identify compliance gaps and propose corrective & preventive actions (CAPA).
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Support a culture of quality and integrity within the organization.
Requirements
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8–10 years of experience in Quality Assurance within clinical research, pharmaceuticals, or life sciences.
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Strong knowledge of ICH-GCP guidelines, OECD GLP principles, NGCMA guidelines, and regulatory requirements.
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Proven experience in internal and external auditing (including vendor and regulatory audits).
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Hands-on experience in CAPA management and quality risk management methodologies.
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Ability to conduct root cause analysis and implement sustainable solutions.
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Strong understanding of Good Documentation Practices (GDP).
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Excellent communication, presentation, and training skills.
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Ability to work cross-functionally and manage multiple stakeholders.
Preferred Qualifications
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Prior experience in a Clinical Research Organization (CRO) or clinical trial QA environment.
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Experience in handling regulatory inspections (NGCMA, FDA, EMA, or other authorities).
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Knowledge of electronic QA systems and computerized system validation in line with GLP/GCP requirements.
