Qualifizierungsexperte Für Verpackungsanlagen (m/w/d)

39med

Wien, Austria
Base: eur 45,600 minimum; bonus: annual bonus + em...
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Qualification of packaging lines
Gmp requirements knowledge
User requirement specifications review
** 39med is seeking a Qualification Expert for Packaging Equipment in Vienna, Austria, to ensure compliance and effectiveness in their biopharmaceutical production processes. The role involves planning and executing qualifications, managing documentation, and participating in audits, requiring technical expertise in packaging technology and regulatory standards. **

Job Summary

  • The role involves planning, preparing, and executing qualifications for complex packaging machinery and in-process control devices within a global biopharmaceutical network.
  • Candidates must possess proven experience in pharmaceutical GMP regulations and the ability to manage audits from authorities like the FDA and AGES.
  • The company offers a competitive salary starting at EUR 45,600 plus benefits including a 12-week paid parental leave program and a yearly bonus.

Matching Summary

Match Score: 75

** 39med is seeking a Qualification Expert for Packaging Equipment in Vienna, Austria, to ensure compliance and effectiveness in their biopharmaceutical production processes. The role involves planning and executing qualifications, managing documentation, and participating in audits, requiring technical expertise in packaging technology and regulatory standards. **

Salary

Base: EUR 45,600 minimum; Bonus: Annual bonus and employee recognition awards available; Benefits: 12 weeks paid parental leave, pension, fitness discount, transport subsidy

Skills & Requirements

Must-have

  • Qualification of packaging lines
  • GMP requirements knowledge
  • User Requirement Specifications review
  • FAT and SAT support
  • SOP creation and updates

Nice-to-have

  • FDA and EMEA regulatory knowledge
  • Project management skills
  • Root cause analysis capability
  • Fluent German and English

Key Requirements

  • Technical or scientific degree (HTL or University)
  • Several years of experience in packaging line qualification
  • Knowledge of automated packaging systems (primary/secondary/tertiary)

Work Rights

Not specified

Tailored Resume

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