Quality Assurance Specialist

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About the Role

We are seeking an experienced QA professional to join MSCR, responsible for ensuring the highest standards of quality and compliance across clinical research operations. The ideal candidate will bring strong expertise in ICH-GCP, regulatory guidelines, and clinical QA processes, with the ability to lead audits, drive CAPA, and support continuous quality improvement initiatives.

Key Responsibilities

• 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 to strengthen product quality.
• 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.
• Perform other QA-related duties as assigned.

Requirements

• 8–10 years of experience in Quality Assurance within clinical research, pharmaceuticals, or life sciences.
• Strong knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Proven experience in internal and external auditing (including vendor audits).
• 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.
• Knowledge of electronic systems used in clinical QA.