Qa Lead

Roche

7 years pharmaceutical qa experience
Aseptic filling process oversight
Cgmp and fda/eu regulatory compliance
The role involves leading the comprehensive review and approval of Batch Production Records to ensure strict adherence to cGMP standards

Job Summary

  • The role involves leading the comprehensive review and approval of Batch Production Records to ensure strict adherence to cGMP standards.
  • Candidates must have extensive experience in aseptic filling operations and new facility project startup readiness.
  • Roche fosters a culture of personal expression and genuine connections where every voice matters in preventing and curing diseases.

Matching Summary

The role involves leading the comprehensive review and approval of Batch Production Records to ensure strict adherence to cGMP standards.

Skills & Requirements

Must-have

  • 7 years pharmaceutical QA experience
  • Aseptic filling process oversight
  • cGMP and FDA/EU regulatory compliance
  • Batch record review and release
  • Supplier quality management
  • APQR compilation and analysis
  • New facility startup readiness

Nice-to-have

  • Auditor training certification
  • Multinational company experience
  • International regulatory network exposure
  • Diplomatic communication skills
  • Continuous improvement initiatives

Key Requirements

  • Degree in pharmaceutical sciences or related field
  • Minimum 7 years in pharmaceutical QA
  • Fluent English communication skills
  • Experience with NMPA, FDA, EMA regulations

Work Rights

Not specified

Tailored Resume

Cover Letter