Quality Assurance – Clinical Operations

The role involves ensuring quality standards and regulatory compliance across clinical operations. The candidate will be responsible for maintaining the Quality Management System (QMS), managing CAPA, deviations, non-conformances, and SOP documentation, and supporting internal audits and quality inspections. The role also requires ensuring compliance with applicable clinical quality regulations and standards, reviewing quality records, identifying process gaps, and coordinating with cross-functional teams to support continuous improvement.
Qualification
Maintain and monitor the Quality Management System (QMS).
Manage CAPA, deviations, non-conformances, and root cause analysis.
Prepare, review, and update SOPs and quality documentation.
Support internal audits, external audits, and regulatory inspections.
Ensure compliance with applicable clinical quality standards and regulatory requirements.
Identify quality issues and coordinate corrective and preventive actions.
Bachelor's or Master's degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
2–3 years of experience in Quality Assurance within clinical operations or a related regulated industry.
Practical experience with QMS, CAPA, deviation management, and SOPs.
Knowledge of ISO 13485, ISO 9001, and applicable clinical quality standards.
Strong documentation, communication, and coordination skills.

Work arrangement
Hybrid