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Quality Control Manager, 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)
  • 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

 

  1. Support HOD to overseeing analytical and microbiological activities in Quality Control (QC) laboratory.
  2. Establish and/or manage ACTRIS QC laboratory workflow procedures.
  3. Process owner for QC laboratory related SOPs.
  4. Ensure compliance in Standard Operating Systems, Good Manufacturing Processes {GMP) & Good Documentation Practice (GDDP) and relevant Safety Regulations.
  5. Review and provide inputs for approval of specification, sampling instructions, test methods and other quality control procedure.
  6. Collaborate with cross-functional teams and provide QC related technical input as required and as defined by projects.
  7. Provide oversight for training, gap and/or risk assessment for activities within QC laboratory.
  8. Provide quality oversight together with quality assurance over the control and release of raw and starting materials, packaging materials, intermediate bulk, finished products, reference and retention samples.
  9. Approval of conditions for outsourced testing.
  10. Provide quality oversight for monitoring of stability of products.
  11. Ensure that the premises and equipment where quality control operations are carried out are appropriate and maintained under suitable conditions.
  12. Support or participate in the process of investigations, root cause analysis, corrective/preventive actions implementation for non-conformance, abnormities, OOS, OOT, deviation etc.
  13. Lead and/or supports internal audits and external inspections preparation for QC laboratory.
  14. Establish annual QC budget proposal.
  15. Other duties and responsibilities as assigned by the Reporting officer or HOD.​​​​​​​​​​​

 

Requirements

 

  1. Minimum Degree in Biomedical Science, Bioengineering, Medical Laboratory Science, Biotechnology, Life Sciences, Microbiology or equivalent.
  2. Minimum 10 years of technical experience in pharmaceutical, medical device, diagnostic laboratory, or relevant manufacturing industry.
  3. Knowledge in GMP / GDP/ HSA regulatory requirement.
  4. Ability to work independently, collaborate cross-functionally, and utilize resources efficiently.

 

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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