Fulfilling Career in Quality Assurance

1 week ago


Singapore beBeeQuality Full time $90,000 - $120,000

Unlock a fulfilling career in quality assurance with our esteemed organization.

We are seeking a Quality Specialist to join our team, responsible for ensuring the highest standards of quality and compliance in our cell and gene therapy manufacturing processes.

As a Quality Specialist, you will be the champion of quality, driving process improvements and ensuring adherence to regulatory requirements.

Key Responsibilities:

  • Initiate, investigate, and close deviations, and manage CAPA processes including effectiveness checks.
  • Review, assess, and manage change controls related to materials, equipment, processes, and documentation.
  • Perform thorough review of executed batch manufacturing records, critical logbooks, and associated documentation.
  • Provide real-time QA support on the manufacturing floor during production, aseptic operations, and changeovers.

Requirements:

  • Bachelor's or Master's in Life Sciences, Biotechnology, Pharmacy or equivalent.
  • 3–5 years of GMP QA/Quality experience, preferably in Cell & Gene Therapy, Biologics, or ATMP manufacturing.
  • Strong knowledge of cGMP, GDP, FDA/EMA standards, PIC/S, ICH Q7/Q9, Annex 1, data integrity principles.
  • Proficiency with quality systems (deviation, CAPA, change control, document control, batch release etc).
  • Excellent communication, analytical, problem‐solving, and collaborative skills.

Benefits:

  • A challenging and rewarding role in a fast-paced industry.
  • The opportunity to work with a talented team of professionals.
  • Professional development and growth opportunities.

Join us as we strive for excellence in quality and innovation



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