Qc物料高级工程师

Bion Environmental Technologies Inc

On-site
7+ years raw material testing experience
Hplc, gc, uv, ir instrument proficiency
Gmp and ich regulatory compliance knowledge
The role involves establishing and maintaining quality standards and inspection procedures for raw materials and packaging materials

Job Summary

  • The role involves establishing and maintaining quality standards and inspection procedures for raw materials and packaging materials.
  • Candidates must possess the ability to independently execute analytical work in a GMP environment while minimizing laboratory errors.
  • Responsibilities include managing third-party laboratories and leading investigations into deviations and Out-of-Specification results.

Matching Summary

The role involves establishing and maintaining quality standards and inspection procedures for raw materials and packaging materials.

Skills & Requirements

Must-have

  • 7+ years raw material testing experience
  • HPLC, GC, UV, IR instrument proficiency
  • GMP and ICH regulatory compliance knowledge
  • OOS investigation and deviation management
  • Third-party laboratory management

Nice-to-have

  • Biologics industry background preferred
  • EP and USP pharmacopoeia familiarity
  • Strong English communication skills
  • Cross-functional team collaboration

Key Requirements

  • Minimum 7 years of relevant testing experience
  • Experience with biologics sector (preferred)
  • Proficiency in MS Office software suite

Work Rights

Not specified

Tailored Resume

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