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Senior/Quality Systems Specialist, ACTRIS

1 week ago

Singapore Consortium for Clinical Research and Innovation Singapore Full time

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(Senior) Quality Systems Specialist, ACTRIS
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)
Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
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 Systems related policies and SOPs such as Quality Management Reviews, Change Control, Deviations, Supplier Quality Assurance, CAPA etc.
Provide quality oversight for quality systems between assigned quality management process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
Review and provide quality systems 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.
Maintain 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 Systems in GMP / GDP / ATMP relevant industry.
Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements.
Proficient in Quality Systems Management Concepts.
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:
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