Junior Quality Assurance

Company Description

Siriraj Institute of Clinical Research (SICRES) is an academic clinical research institute operating under the Faculty of Medicine Siriraj Hospital, Mahidol University. Our mission is to conduct and support clinical research for the benefit of the community to transform patient care and improve human health. Our vision is to become the most trusted academic clinical research organization in Southeast Asia. Our goals include a vibrant and patient-focused research program, sustained collaboration with partners, cutting-edge research that advances clinical practice, cost-effective services that bring value to our clients, and effective and timely communication of our findings.

The Junior Quality Assurance (QA) role supports the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with ISO 9001, ICH-GCP, and applicable regulatory requirements. This position plays a key role in supporting clinical trial and bioequivalence (BE) study activities by assisting with quality documentation, training, compliance monitoring, and audit preparation. The Junior QA works closely with cross-functional teams to promote a strong quality culture across the organization.

Responsibilities

Support and maintain the Quality Management System (QMS) in compliance with ISO 9001, ICH-GCP, and regulatory requirements.

Assist in developing, updating, and controlling quality documents (Policies, SOPs, WIGs).

Support quality training activities for clinical research staff.

Participate in internal, vendor, and external audits, including audit preparation and CAPA follow-up.

Monitor compliance of clinical trial and BE study activities with protocols and quality standards.

Collaborate with cross-functional teams to support continuous quality improvement initiatives.

Qualifications

Bachelor's or higher degree in a science or healthcare related field.

Good knowledge of GLP, ICH GCP and regulatory requirements.

A minimum of 3 years of experience in clinical research including BE study and quality audit.

Strong organizational, communication, and teamwork skills.