Quality Assurance Inspector- GLP

1 day ago


Bengaluru Karnataka India, Karnataka MS CLINICAL RESEARCH Full time

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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