Qp & Quality Manager Compounding Sandyford Dublin 18

BAXTER HEALTHCARE PTY AUS

Sandyford, Dublin, Ireland
Not specified; competitive pyckage; pension, healt...
6-10 years quality implementation in pharma
Eu gmp annex 1 aseptic manufacturing knowledge
Qualified person (qp) certification and experience
The role requires acting as a Qualified Person responsible for implementing the quality management system and leading all aspects of compounded products release

Job Summary

  • The role requires acting as a Qualified Person responsible for implementing the quality management system and leading all aspects of compounded products release.
  • Candidates must ensure strict adherence to EU GMP regulations, specifically Eudralex Volume 4 and Commission Directive 2003/94/EEC, while serving as the primary contact with the HPRA.
  • Baxter offers a competitive package including pension, health insurance, and life assurance alongside a mission to save and sustain lives.

Matching Summary

The role requires acting as a Qualified Person responsible for implementing the quality management system and leading all aspects of compounded products release.

Salary

Not specified; Competitive package; Pension, Health Insurance, Life Assurance included

Skills & Requirements

Must-have

  • 6-10 years Quality implementation in Pharma
  • EU GMP Annex 1 aseptic manufacturing knowledge
  • Qualified Person (QP) certification and experience
  • HPRA regulatory agency liaison experience
  • Sterility assurance and risk management expertise

Nice-to-have

  • Strong leadership skills to motivate teams
  • Ability to operate effectively in fast-paced environment
  • Excellent communication and interpersonal skills
  • Track record of consistently meeting results
  • Data-driven decision making capabilities

Key Requirements

  • 6-10 years pharmaceutical quality experience
  • Proven aseptic manufacture experience
  • Qualified Person (QP) status required
  • Knowledge of EU GMP Annex 1
  • Leadership experience managing diverse teams

Work Rights

Not specified

Tailored Resume

Cover Letter