QA Manager & Qualified Person — Batch Release Lead

Mason Alexander; Dublin; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Mason Alexander is looking for an experienced QA Manager & Qualified Person to lead batch release and QA/QC across the site in South Dublin. You will manage a team of 5, drive QMS ownership, and ensure compliance with licences and international regulations.

You will oversee product release, deviations, investigations, and continuous QMS improvement, while supporting the Production Manager to hit business targets within budget.

Qualificações

• Degree in Pharmacy, Chemistry, Pharmaceutical Chemistry or Biology.
• Qualified Person with HPRA license.
• 5–10 years of QMS experience.
• Experience managing staff and leading teams.
• Proven project leadership and collaboration skills.
• Strong knowledge of EU GMP and HPRA requirements.

Responsabilidades

• Release batches, approve documentation and templates.
• Review compliance of production/analytical methods with GMP/HPRA guidance.
• Review/approve deviations, QC tests and OOS results.
• Investigate product issues and deviations.
• Drive quality culture and site improvement initiatives.
• Oversee Quality System: deviations, incidents, CAPA, changes, material releases.
• Improve QMS with data gathering and trending.
• Deliver and maintain the Validation Master Plan.
• Act as QA contact for regulatory inspections.
• Support Production Manager to meet targets within budget.
• Develop and coach QA/QC staff and succession planning.

Conhecimentos

Analytical Skills

Coaching

Production Management

Change Control

Communication

Readiness

Master Plan

Regulatory Requirements

EP

Formação académica

Degree in Pharmacy/Chemistry/Biology

Descrição da oferta de emprego

Mason Alexander is looking for an experienced QA Manager & Qualified Person to lead batch release and QA/QC across the site in South Dublin. You will manage a team of 5, drive QMS ownership, and ensure compliance with licences and international regulations.

You will oversee product release, deviations, investigations, and continuous QMS improvement, while supporting the Production Manager to hit business targets within budget.