Senior/Quality Specialist

ESCO ASTER PTE. LTD.

Singapore, Singapore
Cgmp compliance knowledge
Deviation investigation and capa management
Batch record review experience
The role involves supporting Quality functions from GMP readiness to ongoing compliance for cell and gene therapy manufacturing

Job Summary

  • The role involves supporting Quality functions from GMP readiness to ongoing compliance for cell and gene therapy manufacturing.
  • Candidates will manage deviations, CAPA processes, and change controls while ensuring adherence to global regulatory standards.
  • The position offers firsthand exposure to emerging modalities and a chance to redefine BioSolutions for One Health.

Matching Summary

Match Score: 75

The role involves supporting Quality functions from GMP readiness to ongoing compliance for cell and gene therapy manufacturing.

Skills & Requirements

Must-have

  • cGMP compliance knowledge
  • deviation investigation and CAPA management
  • batch record review experience
  • change control process oversight
  • audit preparation and support

Nice-to-have

  • cell and gene therapy manufacturing background
  • SAP/MES/LIMS system proficiency
  • CQV/CSV validation experience
  • strong leadership and communication skills
  • ability to work under pressure in cleanroom

Key Requirements

  • Bachelor's or Master's in Life Sciences
  • 3-5 years of GMP QA experience
  • Knowledge of FDA/EMA/PIC/S standards
  • Proficiency with eQMS systems

Work Rights

Not specified

Tailored Resume

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