Specialist I&ii, Manufacturing-lean

Trzdev35

Deviation investigation and change control
Risk assessment and gap analysis
Process optimization and standardization
Responsible for deviation investigation, change control, risk assessment, and compliance system construction within the department to ensure GMP conformity and operational risk identification

Job Summary

  • Responsible for deviation investigation, change control, risk assessment, and compliance system construction within the department to ensure GMP conformity and operational risk identification.
  • Drive continuous improvement by analyzing process flows and data, optimizing production processes, and standardizing operations to enhance efficiency and quality.
  • Support internal and external audits, manage SHE inspections, and lead internal project management for the production department, including cross-departmental collaboration.

Matching Summary

Responsible for deviation investigation, change control, risk assessment, and compliance system construction within the department to ensure GMP conformity and operational risk identification.

Skills & Requirements

Must-have

  • Deviation investigation and change control
  • Risk assessment and gap analysis
  • Process optimization and standardization
  • GMP compliance and operational risk
  • SHE inspection and issue tracking

Nice-to-have

  • Continuous improvement mindset
  • Cross-departmental collaboration
  • Data integrity management
  • Embraces diversity and equality

Key Requirements

  • 3+ years of manufacturing or QA experience in GMP environment
  • Experience with deviation investigation, CAPA, change control
  • Ability to draft SOPs and batch records
  • Bachelor's degree in relevant science field

Work Rights

Not specified

Tailored Resume

Cover Letter