Batch Release Lead

Sanofi

Tuas, Singapore
5 years qa experience in pharmaceutical industry
Expertise in deviation management and batch release
Strong knowledge of good manufacturing practices gmp
The role involves investigating and resolving issues or deviations related to batch release within a fully digitalized Modulus Facility

Job Summary

  • The role involves investigating and resolving issues or deviations related to batch release within a fully digitalized Modulus Facility.
  • Candidates will lead root cause analysis investigations for quality incidents and implement preventive measures to ensure patient safety.
  • This position requires overseeing the review and approval of batch records while ensuring strict compliance with Good Manufacturing Practices.

Matching Summary

The role involves investigating and resolving issues or deviations related to batch release within a fully digitalized Modulus Facility.

Skills & Requirements

Must-have

  • 5 years QA experience in pharmaceutical industry
  • Expertise in deviation management and batch release
  • Strong knowledge of Good Manufacturing Practices GMP
  • Root cause analysis investigation skills
  • Ability to review batch records for compliance

Nice-to-have

  • Experience with digitalized manufacturing facilities
  • Proficiency in analyzing quality performance metrics
  • Collaboration with regulatory support officers
  • Continuous improvement initiative leadership
  • Participation in internal and external audits

Key Requirements

  • At least 5 years of experience in a QA role
  • Focus on deviation management, change control, and batch release processes
  • Strong knowledge of Good Manufacturing Practices (GMP)

Work Rights

Not specified

Tailored Resume

Cover Letter