Senior/quality Operations Specialist, Actris

2 weeks ago

Singapore Consortium for Clinical Research and Innovation Singapore Full time

Overview


The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together six 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)


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.


What you will be working on

  • Provide Quality Oversight for Good Manufacturing Practices / Good Document and Data Practices activities.
  • Assist Quality Managers in providing administration to Quality Operations (Batch Record management, Deviation Investigations, CAPA, Product and Material Disposition etc) related policies and SOPs.
  • Provide quality oversight for Gap and/or quality risk assessments between assigned quality operations process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
  • Review and provide quality operations inputs to relevant documents, training requirements, change controls, deviations and investigations.
  • Support Quality Managers in internal audits, supplier audits and external agency inspections preparation.
  • Support Quality Managers in Quality Management Review.
  • Maintains the ACTRIS Pharmaceutical Quality System.
  • Other responsibilities as assigned by Quality Managers

What we are looking for
EDUCATION, TRAINING

  • Diploma or Degree in Science, Engineering and Life Sciences

EXPERIENCE

  • A minimum of 3 to 5 Years of relevant working experience in Pharmaceutical Quality System in GMP / GDP / ATMP relevant industry.
  • Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements
  • Proficient in Quality Management Concepts.
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