Quality Assurance Inspector- GLP

Job Title: Quality Assurance (QA) – Clinical Research Experience:8–10 years Location:Indiranagar, Bangalore Department:Quality AssuranceAbout the Role MSCR is seeking an experienced QA professional with strong expertise inICH-GCPandGLPprinciples 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 withOECD GLP principlesandNGCMA guidelinesacross 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 inQuality Assurancewithin clinical research, pharmaceuticals, or life sciences. Strong knowledge ofICH-GCPguidelines,OECD GLPprinciples, 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 handlingregulatory inspections(NGCMA, FDA, EMA, or other authorities). Knowledge ofelectronic QA systemsand computerized system validation in line with GLP/GCP requirements.