A Global Leading Pharmaceutical company based in Dublin are seeking a QA Manager(QP) to join their team.
Your New Role
As QA Manager (QP) will have responsibility for the development, implementation and performance of quality assurance for the company and Global External Manufacturing QA.
You will be working closely with the Director of global external manufacturing quality assurance and systems. You will be responsible for the maintenance and creation of QA processes in relation to the MIA, WDA & ASR.
Your New Company
The company is strongly focused on improving human lives through their health care products in over 90 countries globally.
You will be working in a highly collaborative work environment, where they strive to build and retain a strong team by recognising and rewarding excellence, and by creating development opportunities.
Your Duties and Responsibilities as a Quality Assurance Manager
- Manage the QA team to provide quality and compliance support.
- Provide QA expertise in relation to GxP authorisations and the role of MAH.
- Provide QA oversight and expertise for NPI.
- Coach and mentor quality colleagues.
- Ensure site is inspection ready and support regulatory and corporate inspections.
Your Education & Experience
- Bachelor's degree in a related scientific discipline with relevant experience.
- Eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.
- 7 year's experience working in the pharmaceutical industry.
- 4 year's experience in management of QA.
- Batch release for externally manufactured product.
Your Skills & Competencies
- Strong knowledge of GMP & GDP.
- Extensive Experience working within licensed GMP facilities, preferably in QA, line management and production of Medicinal Products.
- Experience in managing BOH inspections and QMS within the EU.
- Lean Six Sigma trained and experience delivering Lean projects desirable
What's in it for you?
As part of this opportunity you will be joining a well-established Pharmaceutical Company as part of a growing dynamic team.
Alongside, working with a Company that has a great culture reputation in the market.
You will receive a competitive salary and benefits package.
Your Next Step
If this sounds like the right role for you, please reply with an updated CV for immediate consideration.
Or if you would like to hear more please feel free to contact Ciara McGrath on 01 8883477 or email.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales