Senior Specialist,QA

LONZA BIOSCIENCE SINGAPORE PTE. LTD.

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

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 within a biopharmaceutical setting.
  • The position requires active participation in QA shopfloor activities, including walkdowns, audits, and the approval of operational documents.

Matching Summary

Match Score: 85

The 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

  • Cell and Gene Therapy (CGT) experience
  • Cross-functional project leadership
  • Stakeholder management skills
  • Site project coordination experience

Key Requirements

  • Degree or Diploma in Science or Engineering
  • Experience in Quality Assurance within cGMP manufacturing
  • Hands-on experience with batch record review and CAPA

Work Rights

Not specified

Tailored Resume

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