Clinical Quality Assurance (QA) Specialist

We are looking for a Clinical Quality Assurance professional responsible for ensuring compliance with quality standards and regulatory requirements across clinical operations. The role includes managing CAPA, deviations, quality documentation, SOPs, audits, investigations, risk assessment, and QMS activities, while coordinating with cross-functional teams to maintain effective quality processes and continuous improvement.

Qualifications

• Bachelor's/Master's degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
• Experience in Clinical QA / Quality Assurance within the healthcare, pharmaceutical, medical device, or clinical environment.
• Strong hands-on experience with CAPA and Deviation Management.
• Knowledge of QMS, SOPs, quality documentation, and compliance requirements.
• Experience in quality investigations, root cause analysis, and risk assessment.
• Exposure to internal/external audits and regulatory inspections.
• Good understanding of applicable GxP / clinical quality standards.
• Strong documentation, communication, and coordination skills.