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Manager, Quality Assurance

3 months ago


Malaysia TIME's group Full time

Quality Assurance & Control (Science & Technology)

Employment Type: Full time

Develop, review, and uphold quality assurance standards for conducting clinical research. Ensure that facilities and resources are provided to meet the requirements of sponsors, contract research organizations (CROs), investigators, and all subjects involved.

Core Duties

  • Ensure that policies and SOPs are created, reviewed, revised, and approved according to the SOP review schedule as necessary.
  • Participate in the development, revision, and implementation of effective Standard Operating Procedures (SOPs), checklists, templates, and compliance guidelines documents, including Quality Assurance (QA) procedures, to support various stages of studies, such as initiation, implementation, close-down, and archiving.
  • Liaise with and provide support to regulatory agencies during mandatory inspections as required.
  • Monitor and manage the quality improvement activities of the department, establishing and tracking quality indicators.
  • Conduct audits on study documentation and regulatory submissions to ensure compliance with study procedures, protocol requirements, and regulatory standards.
  • Provide quality oversight of SOP deviations and Corrective Action/Preventive Action (CAPA).
  • Support internal audits, audit follow-ups, issue tracking, and closure.
  • Assist in creating management review presentations, generate trend and status reports for quarterly updates for Head of Division and Senior Manager.
  • Oversee the Quality Management System (QMS) of the program to ensure compliance with MSQH, JCI, ACHS standards, or any other appropriate accreditation program.

Qualifications & Requirements

  • Bachelor’s Degree in Biomedical Science or closely related field.
  • Minimum of 3-5 years of working experience in Clinical Quality Assurance and/or Clinical Trials.
  • Possess Post Basic in Infection Control.
  • Skills: Extensive working knowledge of GCP Quality Systems, including Good Clinical Practice (GCP).
  • Comfortable working under tight deadlines, highly accurate, detail-oriented, and possessing excellent interpersonal skills.
  • Expected to work with limited supervision, demonstrating considerable initiative and exercising independent judgment.
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