Quality Manager Pilot Plant

Novartis

Schaftenau, Austria
Base: €65,605.54pyear; bonus/equity: not specified...
On-site
Gxp activities oversight
Cgmp/gxp compliance
Iso 13485, 21 cfr 820
The Quality Manager Pilot Plant position at Novartis in Schaftenau, Austria, involves overseeing quality and compliance activities in the assembly of drug device combination products. The role requires a strong background in pharmaceutical quality and operations, with a focus on regulatory compliance and quality assurance

Job Summary

  • The Quality Manager Pilot Plant is responsible for managing all the quality and compliance activities within the Development GDPD Pilot Plant Schaftenau AT.
  • Routine tasks focus on QA oversight of manufacturing, batch record review, failure investigations and deviation, change controls, and release activities.
  • Ensure that compliance with cGMP/ GxP is maintained in TRD.

Matching Summary

Match Score: 85

The Quality Manager Pilot Plant position at Novartis in Schaftenau, Austria, involves overseeing quality and compliance activities in the assembly of drug device combination products. The role requires a strong background in pharmaceutical quality and operations, with a focus on regulatory compliance and quality assurance.

Salary

Base: €65,605.54/year; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • GxP activities oversight
  • cGMP/GxP compliance
  • ISO 13485, 21 CFR 820
  • Data Integrity and GxP
  • Fluent English and German

Nice-to-have

  • Continuous Improvement mindset
  • Dealing with Ambiguity
  • Digital savviness
  • Problem Solving Skills
  • Collaboration

Key Requirements

  • Bachelor's degree (> 5 years pharma quality/operations) or Master's degree (> 3 years pharma quality/operations)
  • Experience with Drug Device combination products
  • Knowledge of cGMP
  • Experience with inspections

Work Rights

Not specified

Tailored Resume

Cover Letter