Senior Quality Assurance Executive

2 weeks ago

Singapore Cordlife Group Limited Full time

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

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