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Quality Operations Specialist

 

Overview


The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together seven national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.


The Business Entities under CRIS include:

 

  • Singapore Clinical Research Institute (SCRI)
  • National Health Innovation Centre (NHIC)
  • Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
  • Precision Health Research, Singapore (PRECISE)
  • Singapore Translational Cancer Consortium (STCC)
  • Cardiovascular Disease National Collaborative Enterprise (CADENCE)
  • SIngapore Medical FOundation AI model (SIMFONI)


Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you!


ACTRIS

 


The Advanced Cell Therapy and Research Institute, Singapore (ACTRIS) was established to meet the increasing clinical demand of using cellular therapeutics to treat various life-threatening diseases. ACTRIS’ vision is to be the national and regional Centre of Excellence for discovery, process development and manufacturing of cellular-based therapeutics across the broad spectrum of immunotherapy and regenerative medicine, encompassing both investigational and approval products for the local market. We also provide value-added services such as workforce training, regulatory facilitation and ancillary material standardization, pertaining to delivery of cellular therapy to patients.

 

 

 

RESPONSIBILITIES

 

  • Lead and provide quality oversight for GMP/CTGTP operations and serve as QA SME for cross‑functional projects.
  • Perform material release, batch record review, and batch disposition.
  • Support facility and equipment qualification activities, including tag‑in/tag‑out processes.
  • Review and approve material specifications, SOPs, protocols, reports, deviations, CAPAs, and change controls.
  • Support audits, inspections, quality risk assessments, and continuous improvement initiatives.
  • Collaborate with Manufacturing, QC, and other functional teams to ensure compliance, data integrity and operational excellence.
  • Perform other duties as assigned by Reporting Officer.

 

 

 EDUCATION & EXPERIENCE

 

  • Diploma or Degree in Biomedical Science, Life Sciences, or a related discipline.
  • 3–5 years of relevant experience in CTGTP, pharmaceuticals, biologics, or other GMP‑regulated environment.
  • Strong understanding of GMP and HSA CTGTP requirements.
  • Proven experience in quality operations, deviation investigation, and change control management.
  • Experience in qualification and validation activities is an advantage.

 

 

SKILLS

 

  • Strong written, verbal, and interpersonal communication skills.
  • Highly organised, meticulous, and detail‑oriented.
  • Able to work independently and collaboratively within a diverse, multi-cultural environment.
  • Good problem‑solving and risk‑based decision‑making skills.

 

What you need to know


Successful candidate will be offered a 3-year contract, renewable. We regret that only shortlisted candidates will be contacted. For more information about CRIS and the Business Entities, visit our websites below:

Apply now »