QA Manager / Qualified Person (QP)

Mason Alexander; Dublin; On-site; EUR 110,000 - 140,000; Full time

Job summary

Mason Alexander seeks an experienced QA Manager & Qualified Person to join their team at a South Dublin facility. The role will own batch release, oversee the QMS, and manage a team of five across QA/QC.

You will ensure compliance with EU GMP, HPRA licences, and relevant product documentation, while driving continuous improvement and regulatory readiness.

Qualifications

• Educated to degree level in Pharmacy, Chemistry, Pharmaceutical Chemistry, Biology or related.
• Qualified Person with HPRA license.
• 5–10 years experience in QMS.
• Experience managing staff and project leadership.
• Strong EU GMP and HPRA knowledge.

Responsibilities

• Own batch release and approve release documentation.
• Review GMP/HPRA, EP and SmPC compliance.
• Review and approve deviations and OOS results.
• Investigate complaints and deviations.
• Drive quality culture and site QA/QC guidance.
• Oversee QMS, deviations, CAPA, change control, materials release.
• Lead continuous improvement of the QMS.
• Deliver and manage Validation Master Plan.
• Act as QA point of contact for regulators and inspections readiness.
• Support Production Manager to meet objectives within budget.
• Develop QA/QC team through coaching and succession planning.

Skills

QA management

Leadership

Regulatory compliance

GMP knowledge

Communication skills

Education

Degree in Pharmacy or related

Qualified Person (QP) HPRA license

5-10 years QMS experience

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

Education & Experience:

• 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