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Quality Assurance Lead (A*STAR High Containment BSL-3 Facility), A*STAR IDL

Agency for Science, Technology and Research (A*STAR)

Singapore

On-site

SGD 70,000 - 100,000

Full time

30+ days ago

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Job summary

A*STAR Infectious Diseases Labs is seeking a Quality Assurance (QA) Lead to manage the QA programme at their High Containment Facility. The role involves overseeing quality assurance processes, leading inspections, and ensuring compliance with regulatory standards. Candidates should have a degree in biomedical sciences and significant experience in a GLP environment, along with strong planning and communication skills.

Qualifications

  • 5 years of experience in a GLP-regulated environment.
  • 3 years in a QA role.
  • Strong knowledge of OECD GLP Principles.

Responsibilities

  • Oversee the development and maintenance of the Quality Assurance Programme.
  • Lead GLP internal inspections and coordinate external inspections.
  • Maintain accurate records of quality activities and inspection findings.

Skills

Attention to detail
Planning skills
Interpersonal communication

Education

Bachelor’s degree in biomedical sciences or related field

Job description

A*STAR Infectious Diseases Labs (A*STAR IDL) aims to be the global leader in infectious diseases through scientific excellence in research and innovation to enhance human health and respond to future pandemics.

A*STAR IDL is seeking for a Quality Assurance (QA) Lead to oversee and manage the QA programme of our A*STAR High Containment (BSL-3) Facility, hosted at A*STAR IDL. The QA Lead will serve as the key point of contact for quality assurance matters, internal and external audits, and risk-based decision-making processes to support research and operational excellence.

Job Description:

  • Oversee the development, implementation and maintenance of Quality Assurance Programme.
  • Ensure documentation (SOPs, deviations, CAPA) is current, controlled and compliant.
  • Lead GLP internal inspections and coordinate external GLP inspections by regulatory bodies.
  • Report inspection findings to the Study Director and Test Facility Management, support the preparation and review of final study plan and report.
  • Maintain accurate records of quality activities, inspection findings, training logs, corrective actions and other relevant documentation.
  • Develop and maintain training programs related to quality and compliance.
  • Collaborate closely with biosafety officers, facility management and researchers to ensure safe and compliant operations.

JobRequirements:

  • Bachelor’s degree or higher in biomedical sciences, or related field.
  • At least 5 years of experience in a GLP-regulated environment, with a minimum of 3 years in a QA role.
  • Strong knowledge and familiarity of OECD GLP Principles and regulatory expectations.
  • Meticulous in record and inventory keeping.
  • Excellent planning skills, well-organized and detailed oriented.
  • Possess strong interpersonal, oral and written communication.
  • Able to manage multiple priorities, work independently, and provide leadership within the QA team.
  • This role requires the use of personal protective equipment (PPE), including respiratory protection, during work-related activities such as training, emergency response, and inspections, in accordance with workplace safety and health guidelines.
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