QA Manager / QP

Mason Alexander; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical Skills

Coaching

Production Management

Change Control

Communication

Readiness

Master Plan

Regulatory Requirements

EP

Education

Degree in Pharmacy/Chemistry/Biology

Job description

Global pharmaceutical company with a production facility in South Dublin are seeking an experienced QA Manager & Qualified Person to join their team.

This is an exciting opportunity for an experienced QP to take ownership of batch release, the QMS and managing a team of 5 across QA/QC function.

As QA Manager & Qualified Person, you will have responsibility for the batch release of sterile injectable products and ensure ongoing compliance with product licences and international regulatory requirements.

Responsibilities:

• Product Release, approving batch documentation, quality control and related (master) templates.
• Reviewing compliance of production and analytical methods with GMP/HPRA guidelines, EP and SmPC.
• Reviewing and approving deviations, QC tests and results, managing Out of specification results.
• Investigate manufactured products in case of complaints or externally reported deviations.
• Implement a Quality Culture: influence the site personnel and management and promote a culture of excellence.
• Oversight of the Quality System, managing deviations, incidents and investigations, OOS, CAPA, Change control and release of incoming materials.
• Continuous improvement of the QMS for purpose of regular gathering and trending of all quality related data.
• Managing the continual improvement plan to ensure the site is always improving on quality.
• Delivering and managing of the site Validation Master Plan, ensuring production occurs in a validated state.
• Quality point of contact of regulatory inspectorates and ensuring inspection readiness at all times.
• Assist the Production Manager and Site Lead to meet company objective and targets both commercially and ensuring operating with budgets whilst maintaining compliance.
• Manage and develop QA/QC teams, including coaching, performance reviews, career development and succession planning.

Requirements:

• Educated to degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry, Biology or related.
• Qualified Person and experience as QP on a HPRA license.
• 5-10 Years Experience in QMS.
• Experience in the overall management of staff.
• Project leadership skills.
• High technical aptitude as well as good communicative and interpersonal skills.
• Excellent and up to date working knowledge of current EU GMP and HPRA requirement for medicinal products.

It is a permanent role, 5 days on site.

• 
  Seniority Level
  Mid-Senior level
• 
  Industry
• Pharmaceutical Manufacturing
• 
  Employment Type
  Full-time
• 
  Skills
• Career Development
• Analytical Skills
• Coaching
• Production Management
• Change Control
• Communication
• Readiness
• Master Plan
• Regulatory Requirements
• EP