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
