Requirements
- Diploma or Degree with 3 years of working experience in Quality System, preferably in healthcare and/or Health Services
- Responsible for the administration of CAPA, DCR, Internal Audit and CCR in the organization.
- Assist the quality manager in the management of Quality systems in the organization.
- Ability to handle tight deadlines and irregular situations
- Must be a team player with good coordination
- Must be meticulous and systematic
- Candidates with more experience will be considered for a Assistant Manager role
Description
- Responsible for maintaining Quality Systems in the company.
- Responsible for monitoring and reviewing quality indicators and quality control reports across departments.
- Maintenance of organization’s quality management system in compliance to:
- regulatory requirements; MOH Healthcare Services Act and other regulatory relevant to CGL’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 CGL’s services/products
- Follow up and assist in deviations/ non-conformances (CAPA) for root cause analysis, rectification and process improvement
- Assist in the performance of risk assessments for company’s activities.
- Monitor quality indicators and review quality control related reports.
- Performance of Internal Audits and record checking and support External Audit to ensure compliance with regulatory and accreditation standards.
- Assist regional office on quality matters.
- Maintains electronic and written records/ reports.
- 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
