Process Deviations Investigation Senior Specialist (f/m/d)

Rezonbio

Duchnice, Poland
Competitive salary; annual + special occasion bonu...
On-site
6+ years qms experience
Process deviation investigation leadership
Root cause analysis expertise
This role requires leading cross-functional investigations for major and critical process deviations while ensuring timely closure aligned with QA Operations

Job Summary

  • This role requires leading cross-functional investigations for major and critical process deviations while ensuring timely closure aligned with QA Operations.
  • Candidates must possess over six years of direct Quality Management System experience including handling deviations, CAPAs, and Out-of-Specification results.
  • The position offers competitive compensation, private medical care, life insurance, and free transportation on dedicated lines in Duchnice, Poland.

Matching Summary

This role requires leading cross-functional investigations for major and critical process deviations while ensuring timely closure aligned with QA Operations.

Salary

Competitive salary; Annual and special occasion bonuses; Benefits include private medical care, pension programs, and flex budget

Skills & Requirements

Must-have

  • 6+ years QMS experience
  • Process deviation investigation leadership
  • Root cause analysis expertise
  • CAPA definition and closure
  • Regulatory inspection experience

Nice-to-have

  • Cross-functional collaboration skills
  • Advanced English proficiency
  • Strong analytical thinking
  • Ability to translate technical language
  • Team knowledge sharing

Key Requirements

  • Higher education in chemistry, biotechnology, or related field
  • 6+ years pharmaceutical/biotech industry experience
  • 6+ years direct QMS experience
  • Experience with FDA/EMEA/GMP regulatory inspections

Work Rights

Not specified

Tailored Resume

Cover Letter