Senior Executive Quality Assurance - #1097846

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: o regulatory requirements; MOH Healthcare Services Act and other regulatory relevant to CGL’s services and products o 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