Senior Specialist, Quality Assurance

LONZA BIOSCIENCE SINGAPORE PTE. LTD.

Singapore
Cgmp and gdocp compliance knowledge
Batch record review and lot genealogy
Deviation investigation and capa implementation
This role involves reviewing executed batch records and documentation to ensure strict compliance with cGMP and GDocP standards

Job Summary

  • This role involves reviewing executed batch records and documentation to ensure strict compliance with cGMP and GDocP standards.
  • The incumbent will lead deviation investigations, approve change controls, and oversee the timely closure of quality events.
  • Candidates must possess hands-on experience in a cGMP manufacturing environment, preferably within biopharmaceuticals or Cell and Gene Therapy.

Matching Summary

Match Score: 85

This role involves reviewing executed batch records and documentation to ensure strict compliance with cGMP and GDocP standards.

Skills & Requirements

Must-have

  • cGMP and GDocP compliance knowledge
  • Batch record review and lot genealogy
  • Deviation investigation and CAPA implementation
  • Change control and document approval
  • Regulatory and customer audit participation

Nice-to-have

  • Experience in Cell and Gene Therapy manufacturing
  • Cross-functional project leadership skills
  • Strong stakeholder management capabilities
  • Site project coordination experience

Key Requirements

  • Degree or Diploma in Science or Engineering
  • Experience in Quality Assurance within cGMP manufacturing
  • Proven ability to lead investigations and change controls

Work Rights

Not specified

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