(Senior) Quality Compliance Specialist, ACTRIS
Senior / Quality Compliance & Training Specialist, ACTRIS
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.
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 Compliance related policies and SOPs.
- Author and/or Process Owner for Quality Assurance related policies and SOPs.
- Provide quality oversight for Gap and/or quality risk assessments between assigned quality management process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
- Review and provide compliance inputs to relevant documents, training requirements, change controls, deviations and investigations.
- Lead and/or support internal audits and external inspections preparation.
- Provide oversight for ACTRIS Quality Risk Management, including conducting and managing ACTRIS Quality Risk Assessments.
- Maintains the ACTRIS Pharmaceutical Quality System.
- Other responsibilities as assigned.
Training Administration
- Support the administration of the GMP training program.
- Maintain accurate and up‑to‑date GMP training records.
- Track training assignments and completion status.
- Support onboarding and periodic GMP training activities.
Job Requirements
- Diploma or Degree in Science, Engineering and Life Sciences
- 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 / HSA regulatory requirements
- Proficient in Quality 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:
CRIS – https://www.cris.sg
SCRI – https://www.scri.edu.sg
NHIC – https://www.nhic.sg
ACTRIS – https://www.actris.sg
PRECISE – https://www.npm.sg
STCC – https://www.stcc.sg