Senior Specialist, Quality Assurance (Fixed Term)

LONZA BIOSCIENCE SINGAPORE PTE. LTD.

Singapore
**
Cgmp and gdocp compliance knowledge
Batch record review and approval
Deviation investigation and capa implementation
** LONZA BIOSCIENCE SINGAPORE PTE. LTD. is seeking a Senior Specialist in Quality Assurance for a fixed-term role, requiring expertise in cGMP compliance, documentation oversight, and quality management in a biopharmaceutical context. The ideal candidate should possess a degree in Science or Engineering and relevant experience in Quality Assurance, particularly within the cell and gene therapy sector. **

Job Summary

  • The role involves reviewing executed batch records and documentation to ensure strict compliance with cGMP and GDocP standards.
  • Candidates will lead investigations, manage change controls, and oversee the timely closure of quality events including deviations and CAPAs.
  • This position requires active participation in QA shopfloor activities, walkdowns, and audits conducted by regulatory bodies or customers.

Matching Summary

Match Score: 75

** LONZA BIOSCIENCE SINGAPORE PTE. LTD. is seeking a Senior Specialist in Quality Assurance for a fixed-term role, requiring expertise in cGMP compliance, documentation oversight, and quality management in a biopharmaceutical context. The ideal candidate should possess a degree in Science or Engineering and relevant experience in Quality Assurance, particularly within the cell and gene therapy sector. **

Skills & Requirements

Must-have

  • cGMP and GDocP compliance knowledge
  • batch record review and approval
  • deviation investigation and CAPA implementation
  • change control and document oversight
  • regulatory and customer audit participation

Nice-to-have

  • Cell and Gene Therapy experience
  • cross-functional project leadership
  • stakeholder management skills
  • site project coordination ability

Key Requirements

  • Degree or Diploma in Science or Engineering
  • Experience in cGMP manufacturing environment
  • Hands-on experience with batch record review

Work Rights

Not specified

Tailored Resume

Cover Letter