Specialist I&ii, Manufacturing-lean

Zse68

Deviation investigation and change control
Gmp compliance and risk assessment
Production process optimization and standardization
The role is responsible for managing deviations, CAPA effectiveness, and driving continuous improvement within the manufacturing department

Job Summary

  • The role is responsible for managing deviations, CAPA effectiveness, and driving continuous improvement within the manufacturing department.
  • The specialist supports audit preparation, SHE inspections, and cross-departmental projects to enhance production efficiency and quality.
  • The company embraces diversity and equality of opportunity and is committed to building an inclusive and diverse team representing all backgrounds.

Matching Summary

The role is responsible for managing deviations, CAPA effectiveness, and driving continuous improvement within the manufacturing department.

Skills & Requirements

Must-have

  • Deviation investigation and change control
  • GMP compliance and risk assessment
  • Production process optimization and standardization
  • CAPA and quality management tools
  • SOP and batch record documentation
  • Internal and external audit preparation
  • Cross-departmental project collaboration

Nice-to-have

  • Team collaboration and communication skills
  • Problem solving ability
  • English listening, speaking, reading, and writing skills

Key Requirements

  • Bachelor's degree in cell biology, molecular biology, statistics or related
  • Minimum 3 years experience in cell culture, aseptic operation, GMP production or QA
  • Strong GMP drug production concept
  • Experience with deviation investigation, CAPA, and change control
  • Ability to independently draft SOPs and batch records
  • Good English proficiency
  • Teamwork and communication skills

Work Rights

Not specified

Tailored Resume

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