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Senior/Quality Engineering 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)
  • 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

 

The quality specialists of Quality Engineering support Quality Validation and Sterility Assurance activities during routine GMP operations.

 

  • Provide Quality Oversight for Good Manufacturing Practices / Good Document and Data Practices activities.
  • Assist Quality Managers in providing administration to Quality Engineering (Qualification and Validation, Sterility Assurance, Preventive Maintenance and Calibrations, Statistical interpretation, Track and Trend  etc) related policies and SOPs.
  • Provide quality oversight for Gap and/or quality risk assessments between assigned quality validation and sterility assurance process and applicable CTGTP / GMP / GDP regulations, guidance and industry standards.
  • Provide guidance in risk based validation and sterility assurance approaches in validation rigor, release strategies to ensure Facilities, Utilities, Equipment, Process, Cleaning, Analytical Methods, Shipping and transportation are fit for their intended GMP purposes.
  • Review Qualification and Validation packages in areas of Facilities, Utilities, Equipment, Process, Cleaning, Analytical Methods, Shipping and transportation.
  • Review and provide qualification validation and sterility assurance 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.
  • Other responsibilities as assigned by Quality Managers and Head of Quality

  

What we are looking for 

 

EDUCATION, TRAINING

 

  1. Degree in Science, Engineering, Microbiology and Life Sciences
  2. Certified Quality Manager (Preferred)

 

EXPERIENCE

 

  1. A minimum of 5 to 8 Years of relevant working experience in Pharmaceutical Quality Systems in GMP / GDP / ATMP relevant industry.
  2. Relevant knowledge in GMP / GDP / HSA / HPRA regulatory requirements.
  3. Proven strong knowledge in best practices of validation and sterility assurance.
  4. 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:

 

 

Apply now »