QA Manager / QP

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