Requirements

Degree with at least 3 years of working experience in Quality System (preferably in Healthcare, Bio/Pharma, Health Services, biotechnology/biotherapies related industry)

Good communication skills

Team player with good coordination

Meticulous, analytical and systematic

Candidates with more experience will be considered for a Assistant Manager role

Descriptions

Maintenance of organization's quality management system in compliance to:

- regulatory requirements; MOH Healthcare Services Act and other regulatory relevant to the company's services and products

- accreditation and certification standards; AABB (Association for the Advancement of Blood & Biotherapies), FACT (Foundation for the Accreditation of Cellular Therapy), GDP-MDS SS 620 (Good Distribution Practice for Medical Devices) and other standards when required for the company's services/products

Ensure requirements for AABB, FACT as well as MOH license guidelines are implemented and maintained

Follow up and assist in deviations/ non-conformances (CAPA) for root cause analysis, rectification and process improvement

Performance of Internal Audits and record checking and support External Audit to ensure compliance with regulatory and accreditation standards.

Manage the Document Control system for the organization and ensure staff complies with the use of controlled and approved documents.

Support supplier/ vendor qualification and audits

Support change control activities

Responsible for maintaining Quality Systems in the company.

Responsible for monitoring and reviewing quality indicators and quality control reports across departments.